Status:
COMPLETED
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
Lead Sponsor:
BeiGene
Conditions:
Advanced High-grade Ovarian Cancer
Triple Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to evaluate the safety, tolerability, PKharmacokinetic profile and treatment effect of pamiparib in Chinese participants with advanced high-grade ovarian cancer (including fallo...
Eligibility Criteria
Inclusion
- Key
- Participants have voluntarily agreed to participate by giving written informed consent.
- Age 18 years (including 18 years) on the day of signing informed consent.
- Participants meet the following eligibility criteria for the corresponding part of the study: 1) In Phase 1 portion: The participants must have a histologically or cytologically confirmed locally advanced or metastatic cancer, either triple-negative breast cancer or epithelial, non-mucinous, high-grade ovarian cancer (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available.
- 2\) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation 4. Participants must have measurable disease as defined per the RECIST, version 1.1.
- 5\. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Key
Exclusion
- Participants who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy.
- Participants who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
- Participants who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
- Untreated and/or active brain metastases.
- Prior therapies targeting poly (ADP-ribose) polymerase (PARP).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03333915
Start Date
December 21 2016
End Date
August 11 2021
Last Update
February 4 2025
Active Locations (6)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
3
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
4
Hunan Cancer Hospital
Changsha, Hunan, China, 410013