|
Health Condition(s) or Problem
|
Metastatic Solid Tumor; Breast Cancer; Ovarian Cancer
|
|
Lay Summary
|
The purpose of the first part of the study is to evaluate the safety of different doses and
dosing regimens of oral rucaparib administered daily to patients with solid tumors.
The purpose of the second part of the study is to determine the safety and clinical activity
of oral rucaparib administered daily to patients with a gBRCA mutation and locally advanced
or metastatic breast cancer or platinum-sensitive relapsed ovarian cancer.
(from ClinicalTrials.gov)
|
|
Who can enter the trial
|
Inclusion Criteria:
(PART 1)
- All cohorts (Dose Escalation and R2PD expansion): Adequate bone marrow, hepatic
(liver), renal, and cardiac function.
- All cohorts: Locally recurrent or metastatic solid tumor (includes lymphoma, all
types of breast cancer) that has progressed on standard treatment.
- R2PD Expansion cohort only: Documented deleterious gBRCA mutation.
OR
(PART 2)
- Locally advanced or metastatic breast cancer associated with a gBRCA mutation that
has relapsed following prior treatment, is not HER2+, and is measurable. One to three
regimens in locally advanced/metastatic setting permitted.
- Ovarian cancer associated with a gBRCA mutation that has relapsed >6 months
following platinum-based prior treatment and is measurable. Two to four prior
treatment regimens permitted.
Exclusion Criteria:
(ALL)
- History of prior cancer except for non-melanoma skin cancer, curatively treated solid
tumor (>5 years ago without evidence of recurrence), and synchronous endometrial
cancer (Stage 1A) with ovarian cancer.
- Prior treatment with any PARP inhibitor, including rucaparib. Patients who received
prior iniparib are eligible.
- Untreated or symptomatic central nervous system metastases.
- Impaired cardiac function or clinically significant cardiac disease.
- Prior gastrectomy or upper bowel removal or any gastrointestinal disorder that would
interfere with the absorption of rucaparib.
|
|
Who cannot enter the trial
|
Inclusion Criteria:
(PART 1)
- All cohorts (Dose Escalation and R2PD expansion): Adequate bone marrow, hepatic
(liver), renal, and cardiac function.
- All cohorts: Locally recurrent or metastatic solid tumor (includes lymphoma, all
types of breast cancer) that has progressed on standard treatment.
- R2PD Expansion cohort only: Documented deleterious gBRCA mutation.
OR
(PART 2)
- Locally advanced or metastatic breast cancer associated with a gBRCA mutation that
has relapsed following prior treatment, is not HER2+, and is measurable. One to three
regimens in locally advanced/metastatic setting permitted.
- Ovarian cancer associated with a gBRCA mutation that has relapsed >6 months
following platinum-based prior treatment and is measurable. Two to four prior
treatment regimens permitted.
Exclusion Criteria:
(ALL)
- History of prior cancer except for non-melanoma skin cancer, curatively treated solid
tumor (>5 years ago without evidence of recurrence), and synchronous endometrial
cancer (Stage 1A) with ovarian cancer.
- Prior treatment with any PARP inhibitor, including rucaparib. Patients who received
prior iniparib are eligible.
- Untreated or symptomatic central nervous system metastases.
- Impaired cardiac function or clinically significant cardiac disease.
- Prior gastrectomy or upper bowel removal or any gastrointestinal disorder that would
interfere with the absorption of rucaparib.
|
|
What will happen
|
Drug; Rucaparib; Oral tablets administered daily with 8 oz (240 mL) of water on an empty stomach or with food; 21-day cycles of treatment. In Part 1, the initial dose level is 40 mg/day (once a day); doses and dosing frequency(e.g. twice a day or three times a day) will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. Patients enrolled in Part 2 will receive the RP2D for continuous 21-day treatment cycles.; Rucaparib (Breast Cancer); Rucaparib (Ovarian Cancer); CO-338; PF 01367338, AG 14699
|
|
Primary aim
|
Incidence of Grade 3 or 4 adverse events and clinical lab abnormalities defined as DLTs (Part 1); PK Profile for Single Dose and at Steady State; Overall Response Rate per RECIST version 1.1 (Part 2)
|
|
Secondary Aim
|
PK profile (fasted and fed) (Part 1 only); Day -7 and Day 1 of Cycle 1; No; AUC and Cmax; Change from baseline in QT/QTc interval (ECG) (Part 1 only); Every week (Cycle 1); q3wks (Cycles 2+); Yes; Incidence of AEs, clinical laboratory abnormalities, and ECG abnormalities; Every 1-2 weeks (Cycle 1); q3wks (Cycles 2+); Yes; Duration of response per RECIST version 1.1 (Part 2 only); Every 2-3 cycles of treatment; No; Response per RECIST version 1.1 (Part 1 only); Every 2-3 cycles of treatment; No
|
|
Participant Information Sheet
|
Sorry, not currently available
|
|
Website
|
Sorry, not currently available
|
|
Recruitment Status
|
Recruiting
|
|
Nation
|
England
|
|
Location
|
London
|