Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Hematinics

Vitamins

Amino Acids

Pembrolizumab

Carboplatin

Dexamethasone

Pemetrexed

Immunomodulating Agents

Dexamethasone acetate

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Trace Elements

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid Antagonists

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Glutamine

The glutaminase inhibitor telaglenastat will be administered orally, twice daily with food, every day in combination with standard-of-care pembrolizumab plus chemotherapy by intravenous (IV) infusion every 3 weeks.

Placebo will be administered orally twice daily with food every day in combination with standard-of-care pembrolizumab plus chemotherapy by IV infusion every 3 weeks.

Telaglenastat

Carboplatin Chemotherapy

Pemetrexed Chemotherapy

Pembrolizumab Immunotherapy

Placebo

Orally, once daily beginning 7 days prior to the first dose of pemetrexed and continue until 21 days after the last dose of pemetrexed.

Folic acid 400 -1000 μg

Vitamin B12 1000 μg Intramuscular injection one week prior to the first dose of pemetrexed and once every 3 cycles (9 weeks) thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.

Vitamin B12 1000 μg

For prophylaxis, orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

Dexamethasone 4 mg

Emil Kuriakose, MD

This is a Phase 2, randomized, multicenter, double-blind study of the glutaminase inhibitor telaglenastat with standard-of-care pembrolizumab and chemotherapy versus placebo with standard-of-care pembrolizumab and chemotherapy for first line treatment of metastatic disease in patients with KEAP1/NRF2-mutated, stage IV, nonsquamous, non-small cell lung cancer (NSCLC). The study primary endpoints are PFS per RECIST v. 1.1 and safety. KEAP1/NRF2 mutation status (for eligibility) and STK11/LKB1 status (for stratification) will be determined by next generation sequencing. A commercial liquid biopsy (circulating tumor DNA) NGS test will be provided to study participants free of charge.

KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC

A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat With Pembrolizumab and Chemotherapy Versus Placebo With Pembrolizumab and Chemotherapy in First-Line, Metastatic KEAP1/NRF2-Mutated, Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)

Duration of investigator-determined PFS per RECIST v1.1 in the intent-to-treat (ITT) population

ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria as assessed by the investigator.

DOR is defined as the duration of response for patients achieving a CR or PR

Calithera Biosciences, Inc

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Other Dietary Supplements

Doxorubicin

Liposomal doxorubicin

Sulforaphane

Protective Agents

Processed SFN-rich extract will be purchased in form of caplets from Nutramax Laboratories, Inc. 2208 Lakeside Blvd Edgewood, MD 21040. Caplets containing SFN-rich broccoli sprout extracts from Nutramax Labs will be dispensed to participants in sealed bottles with instructions to keep them in a household freezer. Size of the caplet will be about 2 cm in length. Dosing will be based on weight and will be dosed daily for 12 weeks.

Placebo caplets will comprise of microcrystalline cellulose from Nutramax Labs and will be dispensed to participants in sealed bottles with instructions to keep them in a household freezer. Placebo pills will be identical in appearance to the sulforaphane pills and will be dosed in a similar manner (identical number of pills based on weight, daily dosing and for 12 weeks)

The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or sulforaphane caplets in a daily dose for 12 weeks of: two caplets for individuals \<100 lb., four caplets for individuals 100-200 lb. and eight caplets for individuals \>200 lb. Avmacol or placebo will be prescribed by Dr. Awasthi and will be dispensed by local pharmacy or study coordinators at TTUHSC/UMC Lubbock. We will be doing pill counts to make sure that volunteers have used as directed. We will measure the Sulforaphane level in plasma by well-established method.

sulforaphane

Placebo Oral Tablet

sharda p singh

Catherine Jones, MD

sharda p singh, PhD

nandini Nair, MD PhD

catherine Jones, MD

sriman swarup, MD

Alexander Philipovskiy, MD PhD

Trey Putnam, PhD

Pooja Sethi, MD

Cardiomyopathy is a major complication of doxorubicin (DOX) chemotherapy, and 10-21% of breast cancer patients receiving DOX experience compromised cardiac function. Recent advancements have increased cancer survivorship but it remains clinically challenging to mitigate the cardiotoxic side effects. Although there are several strategies used to reduce the occurrence and severity of DOX-induced cardiotoxicity, they are not particularly effective. Hence, there is an urgent need to develop new strategies that prevent the cardiotoxic effects of DOX but maintain its potency as a cancer therapy. Because the cellular events responsible for the antitumor activity of DOX and DOX-induced cardiotoxicity are distinctly different, it may be possible to develop therapies that selectively mitigate DOX-induced cardiotoxicity. Thus, the investigators propose to test an adjuvant therapy that combines the phytochemical sulforaphane (SFN) with DOX to attenuate DOX-induced cardiomyopathy. SFN activates the transcription factor Nrf2 and induces defense mechanisms in normal cells. Furthermore, SFN inhibits carcinogenesis and metastases and enhances cancer cell sensitivity to DOX, seemingly through Nrf2-independent mechanisms. SFN has also been tested in several clinical trials, although never together with DOX. Our early animal studies suggest that by activating Nrf2, SFN selectively protects the mouse and rat from DOX cardiotoxicity, enhances survival and enhances the effects of DOX on cancer growth in a rat breast cancer model. The investigators suspect that SFN affects DOX metabolism in cancer cells to enhance tumor regression, or it may synergistically activate other key antitumor mechanisms. Hence, SFN may improve the clinical outcome of cancer therapy by (1) attenuating DOX cardiotoxicity and (2) enhancing the effects of cancer treatment on the tumor. Our hypothesis is that SFN protects the heart from DOX-mediated cardiac injury without altering the antitumor efficacy of DOX. In Aim 1, the investigators will conduct an early-phase clinical trial to determine if SFN is safe to administer to breast cancer patients undergoing DOX chemotherapy. In Aim 2, the investigators will determine if SFN decreases DOX-induced inflammatory responses and enhances Nrf2- and SIRT1-target gene expression in breast cancer patients. Notably, transcript and protein signatures in peripheral blood mononuclear cells (PBMCs) can predict cardiac function in patients undergoing DOX chemotherapy for breast cancer. The investigators will also determine if SFN/DOX treatment activates Nrf2- and SIRT1-dependent gene expression, alters the levels of biomarkers for presymptomatic DOX-cardiotoxicity and mitigates the generation of cardiotoxic metabolites in PBMCs and plasma. These studies will facilitate the development of SFN co-treatment as a strategy to enhance the efficacy and safety of DOX cancer therapy.

Determine whether nutritional supplement sulforaphane (SFN) is safe to administer to breast cancer patients undergoing doxorubicin (DOX) chemotherapy. The investigators have identified biomarkers for presymptomatic detection of DOX cardiotoxicity in breast cancer patients and reported that SFN alleviates DOX-induced cardiac toxicity while maintaining its anti-tumor activity in an animal model of breast cancer. SFN is in various stages of preclinical and clinical trials against different types of cancer but its safety and effects on identified markers have never been tested in patients treated with DOX. Sulforaphane is a generally recognized as a safe (GRAS) compound and this compound is currently in 61 different clinical trials including, Cystic Fibrosis, COPD, Melanoma, Breast and prostate cancer etc. (https://clinicaltrials.gov/ct2/results?term=sulforaphane\&pg=1). Avmacol Extra Strength, (Nutramax Laboratories Consumer Care, Inc. Edgewood, MD 21040) an over-the-counter dietary supplement containing broccoli seed and sprout extracts that is rich with sulforaphane, will be used in this study. This is an FDA regulated trial using an investigational drug under IND 141682. Dose considerations were made on the basis of the ongoing clinical trial "Effects of Avmacol Extra Strength® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer" (https://clinicaltrials.gov/ct2/show/NCT03268993). Furthermore, Avmacol Extra Strength has never been tested as an adjuvant to try and protect the heart from DOXs harmful effects. . Therefore, the investigators are proposing to do an early-clinical trial to assess SFN safety in DOX-treated patients and possibly prevent DOX-cardiotoxicity in breast cancer patients.

Our hypothesis is that SFN protects the heart from DOX-mediated cardiac injury without affecting its antitumor efficacy. Here, the investigators will test SFN in combination with DOX-based chemotherapy for breast cancer; the investigators will assess its safety, cardio-protective properties, and anti-cancer efficacy. The investigators will also examine the effect of SFN on the expression of several biomarkers that indicate when a patient cannot tolerate DOX.1 To test our hypothesis, the investigators propose the following Specific Aims.

Aim 1: Demonstrate that co-administration of SFN protects the heart and is not associated with toxicity or reduced tumor response in breast cancer patients undergoing DOX chemotherapy.

The investigators propose a pilot clinical trial to assess the safety of SFN as a co-treatment with DOX chemotherapy. Strategy: Up to seventy breast cancer patients prescribed DOX chemotherapy will be consented then randomly assigned to receive either SFN or placebo during DOX chemotherapy. This sample size includes an additional 10 participants to allow for potential attrition. There will be a 50-50 chance of receiving SFN. The patients will be recruited from the Breast Cancer Clinic (Dr. Jones and Philipovskiy) in the Southwest Cancer Center at TTUHSC/UMC Lubbock. Cardiac function with echocardiography will be assessed and compared between arms for evidence of substantive decrease in DOX cardiotoxicity with SFN compared to placebo. Tumor size will also be compared (based on RECIST criteria) between treatment arms. The investigators will monitor treatment-emergent symptoms, hematological parameters of cancer therapy toxicity, and renal and hepatic function. Blood samples will be collected to assay markers of cardiotoxicity, including B-type natriuretic peptide and troponin.

Aim 2: Determine if SFN alters the levels of known biomarkers of DOX cardiotoxicity and affects the expression of SIRT1- and Nrf2-target genes.

The investigators will measure changes in transcript and protein biomarkers of pre-symptomatic DOX-cardiotoxicity in response to SFN, and will determine if SFN promotes SIRT1- and Nrf2-dependent gene expression. Because Nrf2 upregulates certain detoxifying enzymes, the investigators will measure the plasma levels of cardiotoxic metabolites, doxorubicinol (DOXol). Strategy: Blood will be collected before the start of DOX chemotherapy and after each treatment cycle to isolate peripheral blood mononuclear cells (PBMCs) and prepare plasma. In lieu of tissue biopsies, PBMCs will be used to examine SIRT1 and Nrf2 activity and target gene expression. Multiplex arrays will be used to measure plasma cytokine levels, and plasma DOX metabolites will be assessed with ultrahigh performance liquid chromatography-tandem mass spectrometry. These experiments will provide initial evidence to indicate that SFN activates SIRT1 and Nrf2 pathways in non-cancer tissue of breast cancer patients.

Impact: This will be the first clinical study to assess the safety of SFN as a co-treatment with DOX to mitigate cardiotoxicity in breast cancer patients. Positive findings will be used to justify a larger randomized controlled trial. Subjects will be randomized at a 1:1 ratio.

Study Design and Procedures Study Design. The investigators intend to include up to 70 DOX-naïve women diagnosed with breast cancer undergoing neoadjuvant chemotherapy with no prior cardiac disease and who will receive DOX without Her-2 receptor antagonists (to eliminate possibility of secondary side effects) as part of their clinical care. These potential subjects will be recruited in a randomized, controlled, double blinded pilot study comparing SFN to placebo. The study will be conducted at the Texas Tech University Health Sciences Center, and University Medical Center. The trial will be approved by our local IRB and registered at clinicaltrials.gov. UMC cancer center pharmacist Ajoke A. Tijani, RPh. (Tijani@umchealthsystem.com) will receive placebo and test compound from supplier and will dispense them to test subjects.

Randomization will be achieved with assignment of a subject ID to the study subject. The list of subject IDs will be subsequently assigned either study drug or placebo using a randomizer software such as (www.randomizer.org). The pharmacist dispensing the medication will be aware of the study IDs in relation to the patient identity, in order to be able to dispense the test drug or the placebo per their assigned status as test or control subjects.

Study Drug and Placebo. Processed SFN-rich extract will be purchased in form of caplets from Nutramax Laboratories, Inc. 2208 Lakeside Blvd Edgewood, MD 21040. Caplets containing SFN-rich broccoli sprout extracts or microcrystalline cellulose (placebo) also from Nutramax Labs will be dispensed to participants in sealed bottles with instructions to keep them in a household freezer. Size of the caplet will be about the size of a 1000 mg Vit C pill (about 2 cm in length). The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or SFN caplets in a daily dose for 12 weeks of: two caplets for individuals \<100 lb., three caplets for individuals 100-200 lb. and four caplets for individuals \>200 lb. Avmacol Extra Strength or placebo will be prescribed by Dr. Jones and Philipovskiy and will be dispensed by local pharmacy or study coordinators at TTUHSC/UMC Lubbock. The investigators will be doing pill counts to make sure that volunteers have used as directed. The investigators will measure the Sulforaphane level in plasma by well-established method. 26 The drug and the placebo will be stored at the South West Cancer Center pharmacy based on manufacturer based guidelines and dispensed to each participant at their baseline visit then at DOX infusion visits 1, 2, and 3. Patients will be expected to maintain at least an 80% adherence to the medication regimen, in the absence of prohibitive toxicity. Adherence will be monitored through therapeutic drug level (Plasma sulforaphane levels of 120 ng/ml) monitoring as mentioned above and pill counts. For subjects who do not meet 80% compliance, they will be instructed on the importance of taking the pills as directed, but if their next visit demonstrates less than 80% compliance, they will be withdrawn from the study. As long as participants complete their 4th cycle of DOX chemotherapy treatment the investigators will still use their study data during analysis. If side effects are noted, patient will be asked to notify the study team of the same and will be evaluated within a suitable time frame based on severity of side effects.

SFN is a safe natural isolate. Above doses (30mg/caplet) are considered adequate to maintain intended therapeutic drug levels, while maintaining a simple study design and without significant concerns for drug toxicity It has been used in several clinical trials from doses ranging from 2-200 µmol/day for 2-28 weeks in 25-80 years old subjects without significant side-effects or toxicity (https://clinicaltrials.gov/ct2/results?term=sulforaphane\&Search=Search), yet never in combination with DOX.

Statistical Considerations Data for the primary endpoint (DOX cardiotoxicity) and other binary outcomes will be summarized by treatment arm as number and proportion per arm. The change in DOX-cardiotoxicity rate with SFN compared to placebo will be assessed with a 1-sided Z-test (see Sample-size justification). Tumor size, plasma cardiac biomarkers, cardiac ejection fraction, DOX metabolite levels will be summarized by treatment arm and time point as means and standard deviations and graphed as box plots and profile plots. The investigators will adhere to ANOVA distributional assumptions so that appropriate data transformations can be applied. Data for each continuous variable will be analyzed for differences in group means at each time point with ANOVA or Mann-Whitney-Wilcoxon non-parametric tests at each time point. These tests will employ a more-stringent alpha = 0.02 significance level to adjust for the multiple comparisons without overinflating type II error. For subjects withdrawn from the study or do not complete the study for any reason, as long as they completed their 4th cycle of DOX chemotherapy treatment the investigators will still use their study data during analysis.

Sample-size justification. The number of subjects (35 per treatment arm; 70 total; the investigators expect some attrition, which this sample size addresses) is based on the primary endpoint of DOX-induced cardiac dysfunction, the rate of which was recently observed at our previous institution (UAMS) to be \~25%1. The investigators expect that SFN will decrease this to 5%. The cardiotoxicity rates for each arm will be compared via 1-sided pooled-variance Z-test at an alpha = 0.10. The statistical power of this test, conducted as described, needs to exceed 80% in order for our study to be generally recognized as having adequate statistical power. Our sample size provides the 1-sided pooled-variance Z-test with 83.2% power at 10% alpha to detect the expected 20-point decrease in DOX-toxicity rates from 25% in the placebo arm to 5% in the SFN arm.

The formal consent of each subject, using the IRB-approved consent form, will be obtained before that subject is submitted to any study procedure.

We plan to include 70 DOX-naïve women with breast cancer undergoing neoadjuvant chemotherapy, with no prior cardiac disease and who will receive DOX without Her-2 receptor antagonists as part of their clinical care. Potential subjects will be recruited in a randomized, controlled; double blinded pilot study comparing SFN to placebo. Study will be conducted at the TTUHSC and UMC. The trial is approved by the institutional IRB and will be registered at clinicaltrials.gov. UMC cancer center pharmacist Ajoke A. Tijani, RPh. will receive placebo and test compound from supplier and will dispense them to test subjects. Randomization will be done with assignment of a subject ID to the study subject. The list of subject IDs will be subsequently assigned to either study drug or placebo using a randomizer software.

Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction

Phase II Trial of Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction (CRI18-026)

All data generated from this project will be disseminated across the scientific community as rapidly as possible while adhering to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources, issued in November 2016. The data will be available in password protected files, accessible only to investigators and with read only access to the databases. We will follow the guidelines established by NIH for Data Sharing Policy and Implementation and will ensure that all NIH privacy protection procedures are followed. We will make the dataset available to qualified investigators within 6 months of acceptance of the manuscript describing the main study findings. Investigators who request to use the dataset will be required to obtain IRB approval and to sign a data use agreement form before release of the data.

2D Echo will be used to measure cardiac function amongst patients on DOX therapy who are exposed to sulforaphane or placebo.

Troponin will be used to assess for cardiotoxicity amongst patients on DOX therapy who are exposed to sulforaphane or placebo.

We will use PET imaging for comparison of change in tumor size for patients on DOX therapy with or without sulforaphane.

Texas Tech University Health Sciences Center

Adenocarcinoma

Participants will receive ascending doses of VVD-130037, orally, once daily in 21-day treatment cycles.

VVD-130037

Vividion Clinical Trial Call Center

A FIH study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VVD-130037 in participants with advanced solid tumors.

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors

A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors

Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed.

Vividion Therapeutics, Inc.

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Anti-Infective Agents

Pyrimethamine

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Pyrimethamine will be taken by mouth at a dose of 50 mg once daily for 14 days (+/-2 days) with the last dose the day prior to surgery.

Patients will be instructed to take their dose at approximately the same time each day.

Paul Zolkind, M.D.

Ben Major, Ph.D.

Douglas Adkins, M.D.

Sidharth Puram, M.D., Ph.D.

Ryan Jackson, M.D.

Patrik Pipkorn, M.D., MSCI

Jason Rich, M.D.

Randal Paniello, M.D., Ph.D.

Wade Thorstad, M.D.

Hiram Gay, M.D.

Esther Lu, M.S., Ph.D.

Peter Oppelt, M.D.

NRF2 activation, observed in up to 40% of head and neck squamous cell carcinoma (HNSCC) tumors, plays a critical role in tumor progression, metastasis, and radiation therapy resistance. The investigators have recently discovered that pyrimethamine (PYR) and its analogs have an inhibitory effect on NRF2 activity in vitro and in mouse models via inhibition of dihydrofolate reductase (DHFR).

Pyrimethamine is an established drug that has been used for decades for treatment of protozoan infections and malaria. A growing body of research shows that it has potential antitumor activity, however its activity on growing human tumors has not been previously studied. The primary efficacy goal of this study is to evaluate the activity of pyrimethamine on human tumors as demonstrated by inhibition of DHFR and downregulation of NRF2 pathway activity. On-target inhibition of DHFR by pyrimethamine results in the stabilization and increased protein expression of human DHFR.

The primary efficacy hypothesis of this study is that treatment with pyrimethamine will result in a 50% increase in DHFR protein within the tumor cells as measured by quantitative western blot analysis. Secondarily, among those tumors classified as NRF2-active on pre-treatment biopsy, the investigators hypothesize there will be a 50% reduction in NRF2 activity as measured by SureQuant targeted proteomic analysis.

Pyrimethamine as an Inhibitor of NRF2 in HPV-unrelated Locally Advanced Head and Neck Squamous Cell Carcinoma

Early Phase I Window of Opportunity Biomarker and Safety Trial to Test Pyrimethamine as an Inhibitor of NRF2 in HPV-unrelated, Locally Advanced Head and Neck Squamous Cell Carcinoma

Tilde Sciences

Washington University School of Medicine

sapanisertib

Bradley J Sumrow, MD

This is a multicenter, randomized, open-label Phase 2 study of sapanisertib in biomarker-defined populations of sqNSCLC. Patients with NFE2L2 (the name for gene encoding the protein called NRF2)-mutated or wild-type sqNSCLC should have disease that has progressed on or after at least two prior systemic therapies for metastatic disease including platinum-doublet chemotherapy and a programmed cell death 1 ligand 1 (PD-L1) inhibitor. The study will evaluate sapanisertib monotherapy in patients with relapsed/refractory sqNSCLC as two separate groups: Group A: NFE2L2-mutated sqNSCLC and Group B: NFE2L2-WT sqNSCLC.

NFE2L2 mutation status for all patients will be identified using local or central next generation sequencing (NGS) testing on archival or fresh tissue or circulating tumor deoxyribonucleic acid (ctDNA), the results of which must be reviewed and approved by the Sponsor prior to enrollment. Each group will be randomized 1:1 to one of two doses/schedules of sapanisertib. Approximately 30 NFE2L2-mutant and 20 NFE2L2-wild type patients will be enrolled. Patients will be treated with sapanisertib until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), unacceptable toxicity, withdrawal of consent, or death.

2 dosing schedules: 3 mg once per day (3 mg total) OR 2 mg twice per day (4 mg total)

Group A: 30 participants randomized 1:1 to one of two dosing schedules

Group B: approximately 20 participants randomized 1:1 to one of two dosing schedules

A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer

A Randomized, Open-Label Phase 2 Study of the TORC 1/2 Inhibitor Sapanisertib in Relapsed/Refractory NFE2L2 (NRF2)-Mutated and Wild-Type (WT) Squamous Non-Small Cell Lung Cancer (sqNSCLC)

We do not plan to share the individual participant data with other researchers

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria as assessed by the investigator.

An adverse event (AE) is any untoward, undesired, or unplanned medical occurrence in a patient administered a medicinal product whether or not considered drug related. A serious adverse event (SAE) is an AE that occurs after receiving study treatment (or after signing informed consent and before receiving study treatment if due to a protocol-mandated procedure) that either results in death, is life-threatening, requires inpatient hospitalization, results in persistent or significant disability, results in congenital anomaly or birth defect, or otherwise meets criteria as an important medical event.

DOR will be calculated as the time between the first documentation of partial response (PR) or a complete response (CR) to the first documentation of progressive disease or death, whichever occurs first.

PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first.

OS is defined as the time from randomization to death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC	NCT04265534	Non-Small Cell ... Non-squamous No... Non-Squamous No... KEAP1 Gene Muta... NRF2 Gene Mutat... NFE2L2 Gene Mut...	Telaglenastat Carboplatin Che... Pemetrexed Chem... Pembrolizumab I... Placebo Folic acid 400 ... Vitamin B12 100... Dexamethasone 4...	18 Years -	Calithera Biosciences, Inc
Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction	NCT03934905	Anthracycline R...	sulforaphane Placebo Oral Ta...	18 Years - 89 Years	Texas Tech University Health Sciences Center
Protective Effects of the Nutritional Supplement Sulforaphane on Doxorubicin-Associated Cardiac Dysfunction	NCT03934905	Anthracycline R...	sulforaphane Placebo Oral Ta...	18 Years - 89 Years	Texas Tech University Health Sciences Center
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors	NCT05954312	Advanced Solid ...	VVD-130037	18 Years -	Vividion Therapeutics, Inc.
Pyrimethamine as an Inhibitor of NRF2 in HPV-unrelated Locally Advanced Head and Neck Squamous Cell Carcinoma	NCT05678348	Head and Neck C... Cancer of the H...	Pyrimethamine	18 Years -	Washington University School of Medicine
KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC	NCT04265534	Non-Small Cell ... Non-squamous No... Non-Squamous No... KEAP1 Gene Muta... NRF2 Gene Mutat... NFE2L2 Gene Mut...	Telaglenastat Carboplatin Che... Pemetrexed Chem... Pembrolizumab I... Placebo Folic acid 400 ... Vitamin B12 100... Dexamethasone 4...	18 Years -	Calithera Biosciences, Inc
A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer	NCT05275673	Non-Small Cell ... Squamous Non-sm... Squamous Non-Sm... NFE2L2 Gene Mut...	sapanisertib	18 Years -	Calithera Biosciences, Inc

Spots Global Cancer Trial Database for nrf2

Every month we try and update this database with for nrf2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nrf2

Every month we try and update this database with for nrf2 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nrf2 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.