Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Carcinoma

Adenocarcinoma

Prostatic Neoplasms

Disease Progression

DNA Repair-Deficiency Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Metabolic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Carboplatin

Rucaparib

Tubulin Modulators

Antimitotic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Rucaparib Camsylate

Heather H. Cheng

This phase II trial studies how well docetaxel with carboplatin followed by rucaparib camsylate works in treating patients with metastatic castration resistant prostate cancer (spread outside of prostate and resistant to testosterone suppression) with homologous recombination DNA repair deficiency. Chemotherapy drugs, such as docetaxel and carboplatin, work to stop the growth of cancer cells, by stopping them from dividing or spreading. Rucaparib camsylate may stop the growth of tumor cells with defects in the ability to repair mistakes in DNA by forcing additional errors so that the cancer cells cannot overcome the number of errors and will then die. Giving induction docetaxel and carboplatin followed by maintenance rucaparib camsylate may work better in treating patients with castration resistant prostate cancer.

OUTLINE:

INDUCTION: Patients receive docetaxel intravenously (IV) and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive rucaparib camsylate orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency

PLATI-PARP: A Phase 2 Study of Induction Docetaxel and Carboplatin Followed by Maintenance Rucaparib in Treatment of Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency

Rate of confirmed PSA decrease from baseline, assessed by a local laboratory (PSA50 and PSA90)

The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.

University of Washington

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Cystadenocarcinoma

Disease Attributes

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Uterine Carcinosarcoma

Adenocarcinoma of the Appendix

Soft Tissue Sarcoma

Mirvetuximab soravtansine

Maytansine

Immunoconjugates

Immunologic Factors

Participants receive mirvetuximab soravtansine IV on day 1 and rucaparib PO BID on days 1 through 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Mirvetuximab Soravtansine

Pharmacokinetic Study

Floor Backes, MD

This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and rucaparib camsylate in treating participants with endometrial, ovarian, fallopian tube or primary peritoneal cancer that has come back. Drugs such as mirvetuximab soravtansine are antibodies linked to a toxic substance and may help find certain tumor cells and kill them without harming normal cells. Rucaparib camsylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving mirvetuximab soravtansine and rucaparib camsylate may work better in treating participants with recurrent endometrial, ovarian, fallopian tube or primary peritoneal cancer.

PRIMARY OBJECTIVES:

I. To determine the recommended phase II dose (RPTD) of combination mirvetuximab soravtansine and rucaparib camsylate (rucaparib) in patients with recurrent endometrial, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

SECONDARY OBJECTIVES:

I. To determine the safety and tolerability of combination mirvetuximab soravtansine and rucaparib in study patients.

II. To explore the objective antitumor activity (complete and partial response) of combination mirvetuximab soravtansine and rucaparib as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in the study population.

III. To measure the progression free survival. IV. To evaluate the pharmacokinetics of mirvetuximab soravtansine and rucaparib in combination.

EXPLORATORY OBJECTIVES:

I. Explore additional biomarkers of response. II. Explore mutation characteristics and frequency with treatment response. III. Evaluate if companion diagnostics can be optimized by combining loss of heterozygosity (LOH) score and level of folate receptor a (FR-alpha) expression, and possible additional predictors of response.

IV. Explore mechanisms of secondary resistance to treatment.

OUTLINE: This is a dose escalation study.

Participants receive mirvetuximab soravtansine intravenously (IV) on day 1 and rucaparib orally (PO) twice daily (BID) on days 1 through 21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 30 days and then every 3 months for up to a year.

Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase I Study of Mirvetuximab Soravtansine (IMGN853) and Rucaparib for Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Pharmacokinetics determined by analysis of collected blood samples

Will be evaluated descriptively using frequencies and percentages

Response rate determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Progression-free survival determined by Kaplan-Meier curves.

ImmunoGen, Inc.

Clovis Oncology, Inc.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Digestive System Diseases

Liver Diseases

Gastrointestinal Diseases

Group 1: patients with normal hepatic function Group 2: patients who have moderate hepatic impairment

In Part I, eligible patients will receive a single oral dose of 600 mg rucaparib followed by intensive plasma PK sampling up to Day 7 (hour 144). In Part II, patients may continue to receive continuous oral rucaparib in 28 day cycles.

Rucaparib camsylate

Phase 1, open-label, parallel group, PK, safety and tolerability study in patients with an advanced solid tumor and either normal hepatic function (Group 1, n = 8) or moderate hepatic impairment (Group 2, n = 8) according to the NCI-ODWG criteria. Patients in Group 1 and Group 2 may be enrolled in parallel, with preferential enrollment of Group 2 patients before Group 1 patients. The study will consist of 2 parts: a single-dose PK part (Part I) and a continuous rucaparib treatment part (Part II).

In Part I, eligible patients will receive a single oral dose of 600 mg rucaparib followed by intensive plasma PK sampling up to Day 7 (hour 144). In Part II, patients may continue to receive continuous oral rucaparib in 28 day cycles. The starting dose for all Group 1 patients will be 600 mg BID. The first 2 patients with moderate hepatic impairment (Group 2) that enter Part II will receive a starting dose of 400 mg BID rucaparib; a lower dose of rucaparib may also be set based on PK results observed in Part I. If this initial starting dose is determined to be safe and tolerable as determined by real-time PK data and dose limiting toxicities (DLT) observed during the first 28 days of rucaparib, the starting dose of rucaparib may be increased in subsequent Group 2 patients. The starting dose for Group 2 patients may also be lowered, based on the patients' real time PK and emerging safety data. The Sponsor and key clinical research organization (CRO) staff will review available adverse event, laboratory, and PK data to determine the starting dose for subsequent Group 2 patients, as well as allowing intra-patient dose escalation of rucaparib after Cycle 1.Treatment with rucaparib will continue until progression of disease, unacceptable toxicity, death, loss to follow-up, withdrawal of consent, or other appropriate clinical reason for discontinuation.

Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor

A Phase 1, Open-Label, Parallel Group Study to Determine the Pharmacokinetics, Safety and Tolerability of Rucaparib in Patients With an Advanced Solid Tumor and Either Moderate Hepatic Impairment or Normal Hepatic Function

PK parameter for rucaparib metabolite(s) to be calculated from plasma concentration-time data

PK parameters for rucaparib metabolite(s) to be calculated from plasma and urine concentration-time data

PK parameter for rucaparib metabolite(s) to be calculated from urine concentration-time data

PK parameter of rucaparib to be calculated from the plasma concentration-time data

PK parameter of rucaparib to be calculated from the plasma and urine concentration-time data

PK parameter of rucaparib to be calculated based on urine concentration-time data

PK parameter of rucaparib to be calculated based on the amount of rucaparib recovered in urine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency	NCT03442556	ATM Gene Mutati... BRCA1 Gene Muta... BRCA2 Gene Muta... Castration Leve... Castration-Resi... Homologous Reco... Prostate Carcin... PSA Level Great... PSA Progression Stage IV Prosta...	Carboplatin Docetaxel Laboratory Biom... Rucaparib Camsy... Rucaparib	18 Years -	University of Washington
Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer	NCT03552471	BRCA1 Gene Muta... BRCA2 Gene Muta... Folate Receptor... Recurrent Fallo... Recurrent Ovari... Recurrent Prima... Recurrent Uteri... Recurrent Uteri... Recurrent Uteri... Platinum Resist...	Laboratory Biom... Mirvetuximab So... Pharmacokinetic... Rucaparib Camsy...	18 Years -	Ohio State University Comprehensive Cancer Center
Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor	NCT03521037	Neoplasms	Rucaparib camsy...	18 Years -	pharmaand GmbH
Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer	NCT03552471	BRCA1 Gene Muta... BRCA2 Gene Muta... Folate Receptor... Recurrent Fallo... Recurrent Ovari... Recurrent Prima... Recurrent Uteri... Recurrent Uteri... Recurrent Uteri... Platinum Resist...	Laboratory Biom... Mirvetuximab So... Pharmacokinetic... Rucaparib Camsy...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for rucaparib camsylate