Clinical trial NCT04179396: Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)
Official title: A Phase 1b, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With Metastatic Castration Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Castration Resistant Prostate Cancer
Keywords: CRPC
PARP inhibitor
RAMP
homologous recombination
DNA repair
DNA defect
DNA anomaly
mCRPC
enzalutamide
abiraterone
Zytiga
Xtandi
ADT
AR
ARi
Lead sponsor: pharmaand GmbH
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination with Other Anticancer Agents in Patients with Metastatic Castration Resistant Prostate Cancer


Eligibility criteria: Inclusion Criteria:

* Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form prior to any study-specific evaluation
* Be ≥18 yrs of age at the time the informed consent form is signed
* Be either AR-directed therapy-naive or have received 1-2 lines of AR-directed therapy in the castration-resistant setting.
* Adequate organ function
* ECOG 0 or 1
* Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
* Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
* Have disease progression after initiation of most recent therapy

Exclusion Criteria:

* Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
* Have received greater than 2 previous lines of chemotherapy for mCRPC
* Prior treatment with any PARP inhibitor
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug
* Spinal cord compression, symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks
* Any clinically significant cardiovascular disease
* Taking any concomitant medications or herbs that could interfere or interact with the study drug

Primary outcomes:
measure: Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC.
timeFrame: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment
measure: Incidence of Dose-Limiting Toxicities (DLTs) in Participants Taking Rucaparib in Combination With Other Anticancer Agents for mCRPC
timeFrame: First 2 cycles of rucaparib combination treatment (56 days) for Arm A
Secondary outcomes:
measure: Preliminary Overall Confirmed Response Rate (ORR) of Rucaparib in Combination With Other Anticancer Agents for mCRPC.
timeFrame: 2 years to complete
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Cancer Institute, P.C.
state: Georgia
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
Study officials:
References: