A Phase 2, Open-Label Study of Rucaparib in Patients with Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 1

• Conditions: Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; MedDRA version: 14.1 Level: PT Classification code 10061269 Term: Malignant peritoneal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: HLT Classification code 10016181 Term: Fallopian tube neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000517-20-ES
• Lead Sponsor: Clovis Oncology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-05
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

. Signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to any study-specific evaluation
2. Be ?18 years of age at the time the informed consent form is signed
3. Have a histologically confirmed diagnosis of high-grade epithelial ovarian (serous or endometrioid histology), fallopian tube, or primary peritoneal cancer
? For mixed histology, >50% of the primary tumor must be confirmed to be high-grade
serous or endometrioid upon re-review by local pathology
4. Have relapsed/progressive disease as confirmed by radiologic assessment
5. Received prior platinum-based therapy and have platinum-sensitive disease
a. Received ?1 prior platinum-based treatment regimen; AND
b. Received a platinum-based regimen as their last treatment; continuous or switch maintenance treatment as part of this regimen is permitted; AND
c. Was sensitive to the last platinum regimen. Platinum-sensitive disease is defined as documented radiologic progression >6 months after the last dose of platinum administered in the treatment setting.
6. If <55 years of age at diagnosis, or has prior history of breast cancer, or has close relative (first or second degree) with ovarian cancer or early onset ( 7. Have undergone a biopsy of tumor tissue within 28 days prior to first dose of study drug
and had the tumor tissue confirmed by the central laboratory as being of adequate quality
(at least 20% tumor content with a minimum of 80% nucleated cellular content)
?If tumor tissue obtained from the biopsy is deemed not adequate, and the patient is unwilling or unable to have another biopsy, the patient may be considered for enrollment if archival tumor tissue is provided and deemed of adequate quality. This must occur prior to any treatment with rucaparib.
a. Biopsy must be of solid tumor tissue; ascites is not acceptable.
b. Biopsy must be of sufficient yield (1 to 3 cores [14 to 18 gauge] measuring 1 to 1.5 cm in length) for planned analyses.
8. Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue (1 x 4 ?m section for H&E stain and approximately 12 x 10 ?m sections, or equivalent) available for planned analyses. Cytospin blocks from ascites are not acceptable
? Archival tissue from the initial debulking surgery should be provided, if available. If
neoadjuvant treatment was administered, tissue collected prior to such treatment should be provided, if available. If tumor tissue prior to any treatments administered is not available, then the oldest available tumor tissue should be provided.
9. Have measurable disease as defined by RECIST v1.1
10. Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to the first dose of rucaparib:
a. Bone Marrow Function
i. Absolute neutrophil count (ANC) ?1.5 × 109/L
ii. Platelets >100 × 109/L
iii. Hemoglobin ?9 g/dL
b. Hepatic Function
i. Aspartate aminotransferase (AST) and alanine aminotransferase

Exclusion Criteria

1. History of a prior malignancy except:
a. Curatively treated non-melanoma skin cancer
b. Breast cancer treated curatively >3 years ago, or other solid tumor treated curatively >5 years ago, without evidence of recurrence
2. Prior treatment with any PARP inhibitor, including oral or intravenous rucaparib. Patients who previously received iniparib are eligible
3. Symptomatic and/or untreated central nervous system (CNS) metastases. Patients with
asymptomatic previously treated CNS metastases are eligible provided they have been
clinically stable for at least 4 weeks
4. Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect
that would interfere with absorption of rucaparib
5. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or history of chronic hepatitis B or C
6. Pregnant or breast feeding. Women of childbearing potential must have a negative serum pregnancy test <3 days prior to first dose of rucaparib.
7. Received treatment with chemotherapy, radiation, hormones, antibody therapy or other
immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ?14 days prior to first dose of rucaparib and/or ongoing adverse effects from such treatment > NCI CTCAE Grade 1
8. Received administration of strong CYP1A2 or CYP3A4 inhibitors ?7 days prior to first dose of rucaparib or have on-going requirements for these medications
9. Non-study related minor surgical procedure ?5 days, or major surgical procedure ?21
days, prior to first dose of rucaparib; in all cases, the patient must be sufficiently recovered and stable before treatment administration
10. Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified