Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Kennedy Disease

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Everolimus

Exemestane

Estrogens

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Subjects in the Enobosarm Treatment Group will receive enobosarm 9mg each day by mouth until disease progression or an unacceptable adverse event is observed. The total duration of the study for a subject in the study from screening to follow-up visit is not standardized and will be different for each subject.

Subjects in the Control Treatment Group will receive an ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus or selective estrogen receptor modulator (SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site. The decision of which comparator treatment will be used will be made prior to randomization. After radiographic progression, subjects randomized to the Control Treatment Group may be crossed over to receive enobosarm 9mg.

Enobosarm

Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM)

Barnette

To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).

This study is a multicenter, randomized, open-label, two treatment arm, efficacy and safety study, comprised of two sections, the main study and the post-study extension period. Subjects will be randomized to the two treatment arms in a 1:1 fashion (into the main study), with the opportunity for subjects initially randomized to the Control Treatment Group to cross over to receive the investigational treatment in the post-study extension period.

The primary efficacy endpoint of the study will be the median rPFS. Subjects will continue study treatment until disease progression confirmed by blinded independent central reader (BICR) is observed. A safety follow up visit will occur approximately 30 days after last dose of study drug. Thereafter, survival follow up will be completed monthly for one year. Survival follow up may be completed by phone or records review. After one year, survival follow up will be completed every 90 days.

After radiographic progression (by RECIST 1.1) is confirmed by blinded independent central reader (BICR) and have received approval from Medical Monitor, subjects in the Control Treatment Group may be crossed over to receive enobosarm treatment (9mg per day). Treatment will continue in this population (Enobosarm Post-study Group (EPG)) until radiographic progression (by RECIST 1.1), confirmed by BICR, is observed. The efficacy database for this crossover group will be completely separate from the main portion of the study and the data will be analyzed separately.

Subjects in the Enobosarm Treatment Group will receive enobosarm 9mg each day by mouth until disease progression or an unacceptable adverse event is observed. Subjects in the Control Treatment Group will receive a ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus or selective estrogen receptor modulator(SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site. The decision of which comparator treatment will be used will be made prior to randomization.

Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

Randomized Crossover Ph3 to Evaluate Efficacy/Safety of Enobosarm Monotherapy vs Active Control for Treatment of AR+/ER+/HER2- MBC With AR Staining Previously Treated w/Nonsteroidal Aromatase Inhibitor, SERD & CDK 4/6 Inhibitor

The primary endpoint for the study is the median radiographic progression free survival (rPFS) in the Enobosarm Treatment Group compared to the Control Treatment Group.

Progression will be defined based on RECIST 1.1.

Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (PR or CR) on study

Veru Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Anti-Infective Agents

Docetaxel

Suramin

Tubulin Modulators

Antimitotic Agents

Anthelmintics

Antiparasitic Agents

Antiprotozoal Agents

Anne M Traynor, MD

Rafael Santana-Davila, MD

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Secondary objectives include:

* To compare response rate of patients in both treatment arms
* To compare overall survival of patients in both treatment arms
* To compare toxicity in both treatment arms
* To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes

Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.

Response rate per RECIST 1.1, as follows:

Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify).

Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD

Compare overall survival of participants in both treatment arms.

The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.

The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.

Medical College of Wisconsin

Optimum Therapeutics, LLC

Ohio State University

University of Wisconsin, Madison

AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.

Docetaxel: IV over 60 minutes, 75 mg/m2

Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm.

Suramin: IV over 30 minutes

Docetaxel: IV over 60 minutes. 56 mg/m2

Docetaxel Plus Suramin

Total

18-39 years

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

White, Not of Hispanic Origin

Black or African American, Not of Hispanic Origin

Hispanic or Latino

Asian

Native Hawaiian or Other Pacific Islander

American Indian or Alaska Native

Race/Ethnicity, Customized

United States

Region of Enrollment

Anne Traynor

The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their progression-free survival was therefore purely determined by the arm of randomization and not influenced by the cross-over.

Progression-free Survival in Months

Partial Response

Stable Disease

Progressive Disease

Not Assessed

The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their response rate was determined by the arm of randomization and not influenced by the cross-over.

Response Rate Per RECIST 1.1 Criteria

The 13 participants that crossed over did so after progressing on the standard arm. The overall survival was determined for the arm of randomization without regard of cross-over. Cross-over was provided as option for participants to have the possible benefit of the new treatment.

Overall Survival

The 13 participants that crossed over did so after progressing on the standard arm. Reported here are the number of participants who experienced adverse events on the arm of randomization.

Number of Participants With Toxicity/Adverse Events From Treatment

All participants who yielded good quality PBL samples were included.

Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.

Overall Study

Symptoms and General Pathology

Digestive System Diseases

Gland and Hormone Related Diseases

Recurrence

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Channel Blockers

Anticonvulsants

Gastrointestinal Agents

Dermatologic Agents

Gemcitabine

Fluorouracil

Capecitabine

Sirolimus

Phenytoin

Pancrelipase

Pancreatin

Methoxsalen

alpha-Methyltyrosine

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

Sodium Channel Blockers

Diuretics, Potassium Sparing

Photosensitizing Agents

(Part 1 enrollment complete) SM-88 used with MPS (methoxsalen, phenytoin and sirolimus)

(Part 2 actively enrolling) SM-88 (920 mg per day) used with MPS (methoxsalen, phenytoin and sirolimus) will be administered to 125 evaluable subjects until unacceptable toxicity, disease progression, or any of the treatment discontinuation criteria are met.

Physician's Choice therapy will be administered for a total of 125 evaluable subjects until unacceptable toxicity, disease progression, or any of the treatment discontinuation criteria are met.

SM-88 used with MPS (methoxsalen, phenytoin, sirolimus)

Investigator choice of the following therapies:

Capecitabine, Gemcitabine, and 5-FU

Capecitabine, Gemcitabine, and 5-FU

Giuseppe DelPriore, MD, MPH

A prospective, open-label phase 2/3 trial in metastatic pancreatic cancer subjects who have failed two lines of prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate.

(Part 1 enrollment complete) In the initial stage of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative was evaluated.

(Part 2 actively enrolling) The second part will consist of a subsequent expansion of the trial to further assess safety and efficacy of SM-88 used with MPS containing the selected SM-88 RP2D from Part 1. A total of 250 subjects in the second part will be randomized 1:1 either to the SM-88 arm (125 subjects) or Physician's Choice of therapy for the Control Arm (125 subjects). Subjects should have previously received two lines of prior systemic therapy.

Please refer to Inclusion/Exclusion Criteria and Summary

A Randomized Phase 2/3 Multi-Center Study of SM-88 in Patients With Metastatic Pancreatic Cancer

A Randomized Phase 2/3 Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred

To determine the OS of subjects treated with SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) vs the Control Arm (Physician's Choice).

Tyme, Inc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer	NCT04869943	Metastatic Brea...	Enobosarm Exemestane	18 Years - 100 Years	Veru Inc.
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer	NCT01671332	Carcinoma, Non ...	Docetaxel Suramin Docetaxel	18 Years -	University of Wisconsin, Madison
Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer	NCT04869943	Metastatic Brea...	Enobosarm Exemestane	18 Years - 100 Years	Veru Inc.
A Randomized Phase 2/3 Multi-Center Study of SM-88 in Patients With Metastatic Pancreatic Cancer	NCT03512756	Pancreatic Canc...	SM-88 used with... Capecitabine, G...	18 Years -	Tyme, Inc

Spots Global Cancer Trial Database for third line

Every month we try and update this database with for third line 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 third line

Every month we try and update this database with for third line 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 third line 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.