Trial Outcomes & Findings for Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP) (NCT NCT04179396)

NCT ID: NCT04179396

Last Updated: 2023-06-29

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 8 participants
• Primary outcome timeframe: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment
• Results posted on: 2023-06-29

Participant Flow

Participant milestones

Measure	Arm A: Oral Rucaparib and Enzalutamide Rucaparib: Oral rucaparib will be administered twice daily Enzalutamide: 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.	Arm B: Oral Rucaparib and Abiraterone Rucaparib: Oral rucaparib will be administered twice daily Abiraterone: Abiraterone will be administered once daily with prednisone Arm B was never opened
Overall Study STARTED	8	0
Overall Study COMPLETED	8	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm A: Oral Rucaparib and Enzalutamide n=8 Participants Rucaparib: Oral rucaparib will be administered twice daily Enzalutamide: 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.	Arm B: Oral Rucaparib and Abiraterone Rucaparib: Oral rucaparib will be administered twice daily Abiraterone: Abiraterone will be administered once daily with prednisone Arm B was never opened	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment

Population: Arm B was never open

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).

Outcome measures

Measure	Arm A: Oral Rucaparib and Enzalutamide n=7 Participants Rucaparib: Oral rucaparib will be administered twice daily Enzalutamide: 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.	Arm B: Oral Rucaparib and Abiraterone Rucaparib: Oral rucaparib will be administered twice daily Abiraterone: Abiraterone will be administered once daily with prednisone Arm B was never opened
Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC. Cmin of rucaparib metabolite M324 during 1-week rucaparib only run-in	233 ng/ml Standard Deviation 103	—
Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC. Cmin of rucaparib during 1-week rucaparib only run-in	1345 ng/ml Standard Deviation 529	—
Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC. Cmin of rucaparib during 1st cycle of rucaparib enzalutamide combo treatment	1558 ng/ml Standard Deviation 510	—
Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC. Cmin of rucaparib metabolite M324 during 1st cycle of rucaparib enzalutamide combo treatment	311 ng/ml Standard Deviation 161	—

PRIMARY outcome

Timeframe: First 2 cycles of rucaparib combination treatment (56 days) for Arm A

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

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.

Outcome measures

Measure	Arm A: Oral Rucaparib and Enzalutamide n=6 Participants Rucaparib: Oral rucaparib will be administered twice daily Enzalutamide: 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.	Arm B: Oral Rucaparib and Abiraterone Rucaparib: Oral rucaparib will be administered twice daily Abiraterone: Abiraterone will be administered once daily with prednisone Arm B was never opened
Incidence of Dose-Limiting Toxicities (DLTs) in Participants Taking Rucaparib in Combination With Other Anticancer Agents for mCRPC	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years to complete

Population: Preliminary ORR could only be evaluated in patients with measurable target lesions at baseline. Only 1 patient had measurable disease at baseline that could be evaluated for a tumor response. Arm B was never opened

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.

Outcome measures

Measure	Arm A: Oral Rucaparib and Enzalutamide n=8 Participants Rucaparib: Oral rucaparib will be administered twice daily Enzalutamide: 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.	Arm B: Oral Rucaparib and Abiraterone Rucaparib: Oral rucaparib will be administered twice daily Abiraterone: Abiraterone will be administered once daily with prednisone Arm B was never opened
Preliminary Overall Confirmed Response Rate (ORR) of Rucaparib in Combination With Other Anticancer Agents for mCRPC. Patients with measurable disease at baseline and a confirmed response of CR or PR by RECISTv1.1	1 Participants	0 Participants
Preliminary Overall Confirmed Response Rate (ORR) of Rucaparib in Combination With Other Anticancer Agents for mCRPC. Patients inevaluable for response by RECISTv1.1	7 Participants	0 Participants

Adverse Events

Arm A: Oral Rucaparib and Enzalutamide

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm B: Oral Rucaparib and Abiraterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: Oral Rucaparib and Enzalutamide n=8 participants at risk Rucaparib: Oral rucaparib will be administered twice daily Enzalutamide: 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.	Arm B: Oral Rucaparib and Abiraterone Rucaparib: Oral rucaparib will be administered twice daily Abiraterone: Abiraterone will be administered once daily with prednisone Arm B was never opened
Immune system disorders Contrast media reaction	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment

Other adverse events

Measure	Arm A: Oral Rucaparib and Enzalutamide n=8 participants at risk Rucaparib: Oral rucaparib will be administered twice daily Enzalutamide: 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.	Arm B: Oral Rucaparib and Abiraterone Rucaparib: Oral rucaparib will be administered twice daily Abiraterone: Abiraterone will be administered once daily with prednisone Arm B was never opened
Blood and lymphatic system disorders Anaemia	62.5% 5/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Cardiac disorders Sinus bradycardia	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Gastrointestinal disorders Abdominal distension	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Gastrointestinal disorders Diarrhoea	50.0% 4/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Gastrointestinal disorders Eructation	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Gastrointestinal disorders Nausea	87.5% 7/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Gastrointestinal disorders Retching	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Gastrointestinal disorders Vomiting	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
General disorders Chills	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
General disorders Fatigue	87.5% 7/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
General disorders Feeling abnormal	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
General disorders Influenza like illness	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Immune system disorders Contrast media allergy	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Immune system disorders Hypersensitivity	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Infections and infestations Nasopharyngitis	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Infections and infestations Osteomyelitis	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Injury, poisoning and procedural complications Accidental overdose	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Injury, poisoning and procedural complications Fall	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Injury, poisoning and procedural complications Sunburn	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Alanine aminotransferase increased	37.5% 3/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Aspartate aminotransferase increased	37.5% 3/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Blood creatinine increased	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Blood urea increased	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Creatinine renal clearance decreased	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Lymphocyte count decreased	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Neutrophil count decreased	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Platelet count decreased	50.0% 4/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Protein total decreased	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations Weight decreased	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Investigations White blood cell count decreased	37.5% 3/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Metabolism and nutrition disorders Decreased appetite	75.0% 6/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Metabolism and nutrition disorders Hyperglycaemia	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Metabolism and nutrition disorders Hypertriglyceridaemia	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Metabolism and nutrition disorders Hypoalbuminaemia	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Metabolism and nutrition disorders Hypocalcaemia	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Metabolism and nutrition disorders Hypokalaemia	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Metabolism and nutrition disorders Hypophosphataemia	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Musculoskeletal and connective tissue disorders Bone pain	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Nervous system disorders Ataxia	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Nervous system disorders Cognitive disorder	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Nervous system disorders Disturbance in attention	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Nervous system disorders Dizziness	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Nervous system disorders Dysgeusia	62.5% 5/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Nervous system disorders Syncope	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Renal and urinary disorders Haematuria	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Renal and urinary disorders Proteinuria	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Respiratory, thoracic and mediastinal disorders Dyspnoea	37.5% 3/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	25.0% 2/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Skin and subcutaneous tissue disorders Erythema	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Skin and subcutaneous tissue disorders Rash pruritic	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Skin and subcutaneous tissue disorders Skin exfoliation	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment
Vascular disorders Hypertension	12.5% 1/8 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment	— 0/0 • 2 years, 5 months Adverse events collected from first dose of any study drug to 28 days after last dose of study drug, or data cut date where that is earlier. If a patient experienced the same preferred term multiple times, then the patient was counted only once for that preferred term. Arm B was never opened to enrollment

Additional Information

Medical Information Department

Clovis Oncology, Inc.

Phone: +1 415 409 7220

Email: medinfo@clovisoncology.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
• Publication restrictions are in place

Restriction type: OTHER