Trials / Active Not Recruiting

Active Not RecruitingNCT03943173

Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery

NOW: Neoadjuvant Olaparib Window Trial in Newly Diagnosed BRCA-Mutant Ovarian Cancer

Status: Active Not Recruiting
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 15 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This early phase I trial studies how well olaparib works in treating patients with newly diagnosed BRCA-mutant ovarian, primary peritoneal, or fallopian cancer before surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility of daily olaparib given in the neoadjuvant setting in women with primary advanced high grade non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer. SECONDARY OBJECTIVES: I. Estimate efficacy of olaparib given in the neoadjuvant setting using response rate (by Response Evaluation Criteria in Solid Tumors \[RECIST\] in subjects with measurable disease). II. Estimate proportion of subjects able to proceed immediately to interval tumor reductive surgery (without chemotherapy). III. Determine progression-free survival (PFS). IV. Determine complete pathologic response rate at the time of surgery. V. Determine the toxicity of daily olaparib given in the neoadjuvant setting. VI. Evaluate the toxicity of chemotherapy given after neoadjuvant olaparib. VII. Measure longitudinal symptom burden of study subjects treated with neoadjuvant olaparib and chemotherapy after olaparib. EXPLORATORY OBJECTIVES: I. Explore deoxyribonucleic acid (DNA) copy number and level of ribonucleic acid (RNA) and protein expression in homologous recombination-related pathways before and after treatment with olaparib in women with primary advanced high grade non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer. II. Correlate molecular results to clinical endpoints including response and survival. OUTLINE: Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After treatment, patients either undergo surgery then receive standard chemotherapy for up to 4 cycles or receive standard chemotherapy within 14 days for up to 4 cycles then undergo surgery in the absence of disease progression or unacceptable toxicity at the discretion of the treating physician. After completion of study treatment, patients are followed up at 30 days.

Conditions

Interventions

Type	Name	Description
DRUG	Chemotherapy	Given standard chemotherapy
DRUG	Olaparib	Given PO
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

Start date: 2019-06-07
Primary completion: 2027-06-27
Completion: 2027-06-27
First posted: 2019-05-09
Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03943173. Inclusion in this directory is not an endorsement.