A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (BOUQUET)

Phase 1

• Conditions: Persistent or Recurrent Rare Epithelial Ovarian Tumors; MedDRA version: 20.0Level: PTClassification code: 10061328Term: Ovarian epithelial cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-508194-89-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

Persistent or recurrent epithelial ovarian cancer (EOC) that meets the following criteria: a) Histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (including but not limited to low-grade serous ovarian cancer, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma, and small cell carcinoma of the ovary, hypercalcemic type). A primary gastrointestinal carcinoma must have been excluded. b) Disease that is not amenable to curative surgery, Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Previous treatment with one to four lines of therapy, at least one of which was platinum-based. Hormonal therapy does not count as a line of therapy, Platinum-resistant disease (defined as disease progression during or within 6 months of last platinum therapy) with the following exception: patients with primary platinum-refractory disease are excluded., At the time of prescreening, submission of a representative tumor specimen that is suitable for NGS testing and ER IHC to determine treatment arm assignment and for central pathology review.

Exclusion Criteria

Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer, Current diagnosis of solely borderline epithelial ovarian tumor (formerly considered tumors of low malignant potential), Current diagnosis of non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord-stromal tumors), Current diagnosis of synchronous primary endometrial cancer, Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment, History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer

Study & Design

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