Metastatic Castration Resistant Prostate CancerPhase 1RAMPNCT04179396

Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)

A Phase 1 study testing Rucaparib, Enzalutamide and Abiraterone in people with Metastatic Castration Resistant Prostate Cancer, run by pharmaand GmbH at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Metastatic Castration Resistant Prostate Cancer
What is being tested?: Rucaparib, Enzalutamide and Abiraterone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 3 sitesUnited States
Study dates: 5 Dec 2019to 18 Jan 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Piedmont Cancer Institute, P.C.
Atlanta, Georgia, 30318
University of Minnesota
Minneapolis, Minnesota, 55455
Urology Associates, P.C.
Nashville, Tennessee, 37209

Other trials in United States

About this study

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

Conditions: Metastatic Castration Resistant Prostate Cancer
Being tested: Rucaparib, Enzalutamide, Abiraterone
Keywords: CRPC, PARP inhibitor, RAMP, homologous recombination, DNA repair, DNA defect, DNA anomaly, mCRPC, enzalutamide, abiraterone, Zytiga, Xtandi, ADT, AR, ARi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RucaparibDrug
Also called Rubraca, CO-338
Oral rucaparib will be administered twice daily
EnzalutamideDrug
Also called Xtandi
Enzalutamide will be administered once daily.
Enrollment into Arm A will be prioritized over Arm B until the objectives for Arm A have been achieved.
AbirateroneDrug
Also called Zytiga
Abiraterone will be administered once daily with prednisone

Study groups in NCT04179396
Study group	Role	What they receive
Arm A: Oral rucaparib and enzalutamide	Experimental	Not described Receives: Drug: Rucaparib; Drug: Enzalutamide
Arm B: Oral rucaparib and abiraterone	Experimental	Not described Receives: Drug: Rucaparib; Drug: Abiraterone

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC.
Cmin of rucaparib and its metabolite. Rucaparib only run-in Cmin includes run-in D6, D7 and Cycle 1 D1. All of these samples were collected following rucaparib monotherapy. Rucaparib and other anticancer agent Combination Cmin includes Cycle 1 (D8, D15, and D22).
Measured: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment
Incidence of Dose-Limiting Toxicities (DLTs) in Participants Taking Rucaparib in Combination With Other Anticancer Agents for mCRPC
A DLT is defined according to criteria specified in the protocol and assessed by the investigator, based on toxicity grade (according to the NCI CTCAE v5.0), clinical significance, and possible relationship to the study drug combination. The toxicity cannot be a recognized adverse effect of enzalutamide, abiraterone or prednisone/prednisolone and/or attributable to mCRPC or mCRPC-related processes under investigation.
Measured: First 2 cycles of rucaparib combination treatment (56 days) for Arm A

Secondary outcomes (1)

Preliminary Overall Confirmed Response Rate (ORR) of Rucaparib in Combination With Other Anticancer Agents for mCRPC.
The ORR is defined as the proportion of patients with a documented and confirmed best overall response of complete response (CR) or partial response (PR) per mRECIST v1.1 as assessed by the investigator using local standardized radiological methods e.g. CT, MRI, etc. A complete response (CR) is defined as complete disappearance of all target and non-target lesions together with normalization of tumor biomarkers. A partial response (PR) represents at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD with non-progression of non-target lesions and no new lesions. Overall Response (OR) = CR + PR. A confirmed CR or PR is a response that is maintained and documented on a subsequent tumor assessment at least 4 weeks after initial response. PSA response per PCWG3 criteria is a confirmed PSA response (≥ 50% decrease from baseline) as reflected by local laboratory measurements.
Measured: 2 years to complete

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201918 Jan 2023

First posted27 Nov 2019
Study start5 Dec 2019
Primary completion25 Nov 2021
Study completion18 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04179396
Sponsor's protocol ID: CO-338-107
Acronym: RAMP
Status last verified: Jun 2023
First submitted: 19 Nov 2019
Last updated: 29 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations. Data will be provided by Clovis Oncology.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer

All Metastatic Castration Resistant Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04179396
Acronym / sponsor ID: RAMP / CO-338-107
Conditions: Metastatic Castration Resistant Prostate Cancer
Keywords: CRPC, PARP inhibitor, RAMP, homologous recombination, DNA repair, DNA defect, DNA anomaly, mCRPC
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: pharmaand GmbHIndustry (pharma, biotech, devices)
Study start: 5 Dec 2019 (actual)
Primary completion: 25 Nov 2021 (actual)
Study completion: 18 Jan 2023 (actual)
First posted: 27 Nov 2019 (actual)
Results: Posted 28 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: Oral rucaparib and enzalutamide	Experimental	Drug: Rucaparib, Drug: Enzalutamide
Arm B: Oral rucaparib and abiraterone	Experimental	Drug: Rucaparib, Drug: Abiraterone

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RucaparibAlso: Rubraca, CO-338Oral rucaparib will be administered twice daily	Drug	Arm A: Oral rucaparib and enzalutamide, Arm B: Oral rucaparib and abiraterone
EnzalutamideAlso: XtandiEnzalutamide will be administered once daily. Enrollment into Arm A will be prioritized over Arm B until the objectives for Arm A have been achieved.	Drug	Arm A: Oral rucaparib and enzalutamide
AbirateroneAlso: ZytigaAbiraterone will be administered once daily with prednisone	Drug	Arm B: Oral rucaparib and abiraterone

Primary outcome

Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC.
Time frame: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment
Cmin of rucaparib and its metabolite. Rucaparib only run-in Cmin includes run-in D6, D7 and Cycle 1 D1. All of these samples were collected following rucaparib monotherapy. Rucaparib and other anticancer agent Combination Cmin includes Cycle 1 (D8, D15, and D22).
Incidence of Dose-Limiting Toxicities (DLTs) in Participants Taking Rucaparib in Combination With Other Anticancer Agents for mCRPC
Time frame: First 2 cycles of rucaparib combination treatment (56 days) for Arm A
A DLT is defined according to criteria specified in the protocol and assessed by the investigator, based on toxicity grade (according to the NCI CTCAE v5.0), clinical significance, and possible relationship to the study drug combination. The toxicity cannot be a recognized adverse effect of enzalutamide, abiraterone or prednisone/prednisolone and/or attributable to mCRPC or mCRPC-related processes under investigation.

1 secondary outcome

Preliminary Overall Confirmed Response Rate (ORR) of Rucaparib in Combination With Other Anticancer Agents for mCRPC.
Time frame: 2 years to complete

Results and safety

Results posted to the registry on 28 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Oral Rucaparib and Enzalutamide	8	8
Arm B: Oral Rucaparib and Abiraterone	0	0

Primary outcome: Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC.

Time frame: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment. Mean (Standard Deviation). Unit: ng/ml

Measure	Arm A: Oral Rucaparib and Enzalutamide n = 7	Arm B: Oral Rucaparib and Abiraterone n = 0
Cmin of rucaparib during 1-week rucaparib only run-in	1345 (529)	–
Cmin of rucaparib metabolite M324 during 1-week rucaparib only run-in	233 (103)	–
Cmin of rucaparib during 1st cycle of rucaparib enzalutamide combo treatment	1558 (510)	–
Cmin of rucaparib metabolite M324 during 1st cycle of rucaparib enzalutamide combo treatment	311 (161)	–

Population analysed: Arm B was never open

Primary outcome: Incidence of Dose-Limiting Toxicities (DLTs) in Participants Taking Rucaparib in Combination With Other Anticancer Agents for mCRPC

Time frame: First 2 cycles of rucaparib combination treatment (56 days) for Arm A. Count of participants. Unit: Participants

Measure	Arm A: Oral Rucaparib and Enzalutamide n = 6	Arm B: Oral Rucaparib and Abiraterone n = 0
Value	0	0

Population analysed: Number of participants deemed DLT-evaluable Arm B was never opened

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years, 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Oral Rucaparib and Enzalutamide	2 of 8 (25%)	8 of 8 (100%)	0 of 8
Arm B: Oral Rucaparib and Abiraterone	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Enrollment in the trial was terminated early however sufficient PK and safety data were collected to complete the key objective of elucidating the potential for drug-drug interaction by evaluating PK as well as safety and tolerability of the rucaparib/enzalutamide combination.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations. Data will be provided by Clovis Oncology.

Related trials for Metastatic Castration Resistant Prostate Cancer

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rucaparib, Enzalutamide and Abiraterone in people with Metastatic Castration Resistant Prostate Cancer, run by pharmaand GmbH at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC. (time frame: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04179396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.