Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Breast Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Renal Insufficiency

Melanoma

Head and Neck Neoplasms

Carcinoma, Transitional Cell

Hepatic Insufficiency

Liver Failure

Testicular Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Breast Diseases

Liver Diseases

Gastrointestinal Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Gonadal Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Esophageal Diseases

Genital Neoplasms, Male

Genital Diseases, Male

Testicular Diseases

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Liver Extracts

Veliparib

Tubulin Modulators

Antimitotic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Patients receive veliparib\* PO BID on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 3. Courses repeat every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: \* All patients receive a single dose of veliparib PO on day -6 before course 1 (except patients with very severe renal dysfunction who receive veliparib on day -5 or -6 to coincide with a dialysis day).

Laboratory Biomarker Analysis

Pharmacological Study

Hussein A Tawbi

This phase I trial studies the side effects and the best dose of veliparib when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or cannot be removed by surgery and liver or kidney dysfunction. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with paclitaxel and carboplatin may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To determine the pharmacokinetics and pharmacodynamics of ABT-888 (veliparib) in patients with varying degrees of renal or hepatic dysfunction.

II. To determine the maximum tolerated dose (MTD) of ABT-888 in combination with carboplatin and paclitaxel for patients with varying degrees of liver or kidney dysfunction.

III. To provide dosing recommendations for ABT-888 in combination with carboplatin and paclitaxel based on degree of hepatic and renal impairment.

SECONDARY OBJECTIVES:

I. To define the dose-limiting toxicity (DLT) and other toxicities associated with the use of this combination in patients with varying degrees of renal or hepatic dysfunction.

II. To evaluate the pharmacokinetic parameters of ABT-888, carboplatin, and paclitaxel when administered as a combination in patients with varying degrees of renal or hepatic dysfunction.

III. To evaluate the pharmacodynamic measurement of poly-ADP-ribosylated (PAR) and platinum adducts in tumor cells associated with the use of this combination in patients with varying degrees of renal or hepatic dysfunction.

OUTLINE: This is a dose-escalation study of veliparib.

Patients receive veliparib\* orally (PO) twice daily (BID) on days 1-7 and paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: \* All patients receive a single dose of veliparib PO on day -6 before course 1 (except patients with very severe renal dysfunction who receive veliparib on day -5 or -6 to coincide with a dialysis day).

After completion of study treatment, patients are followed up for 4 weeks.

Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction

An Early Phase 1 Study of ABT-888 in Combination With Carboplatin and Paclitaxel in Patients With Hepatic or Renal Dysfunction and Solid Tumors

Descriptive statistics (mean, standard deviation, median, range) for measurements of PAR levels will provided with 95% confidence intervals (CIs). When sample size permits, a formal statistical test using the Wilcoxon signed rank test will be used to compare the post treatment PAR levels to the baseline levels. When feasible, the level will be compared between responders and non-responders using the Wilcoxon signed rank test.

Descriptive statistics (mean, standard deviation, median, range) for measurements of gamma-H2AX levels will provided with 95% CIs. When sample size permits, a formal statistical test using the Wilcoxon signed rank test will be used to compare the post treatment PAR levels to the baseline levels. When feasible, the level will be compared between responders and non-responders using the Wilcoxon signed rank test.

Standard quantitative and graphical statistical summaries of the derived PK parameters (e.g. area under curve and clearance) will be produced for each organ function cohort. The effect of dysfunction on pharmacokinetics will be explored by comparing each pharmacokinetic parameter across all cohorts using one-way analysis (analysis of variance) or Kruskal-Wallis test. The level of each protein will be compared between responders and non-responders using the Wilcoxon signed rank test.

The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category, grade and dose level. Severe and life-threatening toxicities and adverse event-related deaths (\>= grade 3) will be described on a patient-by-patient basis and will include any relevant baseline data.

Responses will be tabulated by disease diagnosis and by dose level. 95% confidence limits will also be reported on the response rates.

Incidence of stable disease will be tabulated by disease diagnosis and by dose level.

Displayed for all patients and for patients who have responded; no formal statistical analysis is planned.

Abbott

National Cancer Institute (NCI)

Nervous System Diseases

Blood and Lymph Conditions

Symptoms and General Pathology

Carcinoma, Hepatocellular

Cholangiocarcinoma

Urinary Bladder Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Neuroendocrine Tumors

Pleural Neoplasms

Brain Neoplasms

Skin Neoplasms

Thymoma

Thymus Neoplasms

Adrenal Gland Neoplasms

Neoplasms, Unknown Primary

Adenocarcinoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Diseases

Respiratory Tract Diseases

Neoplasm Metastasis

Neoplastic Processes

Lymphatic Diseases

Adrenal Gland Diseases

Bile Duct Cancer

Neuroendocrine Tumor

Adrenal Cancer

Neuroepithelioma

Fluorodeoxyglucose F18

FAPI-46

Radiopharmaceuticals

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Computed Tomography

Gallium Ga 68 FAPi-46

Positron Emission Tomography

18F-FDG

Ethan Lam

Stephanie Lira

Jeremie Calais

This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.

PRIMARY OBJECTIVE:

I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.

SECONDARY OBJECTIVES:

I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.

II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

EXPERIMENTAL OBJECTIVE:

To assess the correlation of 68Ga-FAPI-46 biodistribution with 68Ga-DOTATATE or 18F-DOPA (FDOPA), depending on the specific indication in patients who had them available

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers

PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation

The other PET tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax). The SUV of FAPI PET and the other PET tracers will be tested for correlation.

Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).

Will be correlated with FAP expression in surgically removed or biopsy derived tumor tissue.

2. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-)

Jonsson Comprehensive Cancer Center

Prostatic Neoplasms

Nausea

Sarcoma

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Dermatologic Agents

Emetics

Gastrointestinal Agents

Coal Tar

Genitourinary medical oncologists and study coordinators will identify patients with genitourinary cancers (i.e., bladder cancer, prostate cancer, and testicular cancer) who will receive moderate to high emetogenic chemotherapy regimen.

Patients will collect stool for microbiome analysis at baseline (i.e., 3 +2 days prior to chemotherapy) and again 5-7 days following initiation of chemotherapy.

Blood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy.

Blood and Tissue

Clinical Trials Referral Office

Komal P. Singh, Ph.D., R.N.

Cindy Tofthagen, Ph.D., R.N.

Daniel (Dan) S. Childs, M.D.

The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.

The long-term goal of this study is to alleviate the occurrence of CIN and to improve chemotherapy treatment outcomes. The identification of associations between CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie CIN. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate CIN.

Patients will collect stool for microbiome analysis at baseline (i.e., 3 +2 days prior to chemotherapy) and again 5-7 days following initiation of chemotherapy.

Blood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy. The blood sample will be used for several assays that include gene expression, immune cell profiling, metabolite analytics, and additional omics assays.

Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics

Investigation of Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics

Evaluate the feasibility of patient recruitment by using descriptive statistics to determine number of patients approached and number of patients enrolled.

Evaluate the feasibility of patient retention by using descriptive statistics to determine number of patients who completed the questionnaires at both assessments.

Evaluate the feasibility of patient specimen collection by using descriptive statistics to determine number patients who provided stool samples at both assessments.

Evaluate for changes in alpha and beta diversity as well as composition of the gut microbiome pre- and post-chemotherapy in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Region V3-V5 of the 16s rRNA gene will be targeted for sequencing and submitted to trimmomatic for reads trimming and quality control.

Examine associations between microbial composition functional profiles pre- and post-chemotherapy in patients who report chemotherapy-induced nausea (CIN) after chemotherapy. Change in relative abundance of genus associated with CIN occurrence will be used to predict the function of the genus. We will use PiCrust to perform functional profiling.

Evaluate for differentially abundant metabolites associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling of stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Evaluate for perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling will be performed on stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS), as well as RNA-Seq analyses.

Mayo Clinic

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction	NCT01366144	Breast Carcinom... Carcinoma of Un... Endometrial Car... Esophageal Carc... Liver Failure Lung Carcinoma Malignant Head ... Malignant Testi... Melanoma Metastatic Mali... Ovarian Carcino... Renal Failure Unresectable Ma... Urothelial Carc...	Carboplatin Laboratory Biom... Paclitaxel Pharmacological... Veliparib	18 Years -	National Cancer Institute (NCI)
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers	NCT04459273	Bladder Carcino... Cervical Carcin... Cholangiocarcin... Hematopoietic a... Hepatocellular ... Malignant Adren... Malignant Brain... Malignant Pleur... Malignant Skin ... Malignant Solid... Malignant Testi... Malignant Thymu... Neuroendocrine ... Thyroid Gland C... Urothelial Carc... Cancer of Unkno...	Computed Tomogr... Gallium Ga 68 F... Positron Emissi... 18F-FDG	18 Years -	Jonsson Comprehensive Cancer Center
Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics	NCT05819827	Bladder Cancer Prostate Cancer Testicular Canc... Bladder Carcino... Genitourinary S... Malignant Testi... Melanoma Prostate Carcin... Sarcoma	Blood and Tissu...	20 Years -	Mayo Clinic
Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics	NCT05819827	Bladder Cancer Prostate Cancer Testicular Canc... Bladder Carcino... Genitourinary S... Malignant Testi... Melanoma Prostate Carcin... Sarcoma	Blood and Tissu...	20 Years -	Mayo Clinic
Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction	NCT01366144	Breast Carcinom... Carcinoma of Un... Endometrial Car... Esophageal Carc... Liver Failure Lung Carcinoma Malignant Head ... Malignant Testi... Melanoma Metastatic Mali... Ovarian Carcino... Renal Failure Unresectable Ma... Urothelial Carc...	Carboplatin Laboratory Biom... Paclitaxel Pharmacological... Veliparib	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for malignant testicular neoplasm