Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors

BeiGene

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced High-grade Ovarian Cancer; Triple Negative Breast Cancer

Treatments: Drug: Pamiparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03333915

CTR20160828 (Registry Identifier)

BGB-290-102

Details and patient eligibility

About

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 fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase I, and to evaluate the efficacy and safety of pamiparib in Chinese participants with recurrent epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline breast cancer susceptibility gene 1/gene 2 (BRCA1/2) mutation in phase II.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Participants have voluntarily agreed to participate by giving written informed consent.
2. Age 18 years (including 18 years) on the day of signing informed consent.
3. 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 Criteria:

1. 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.
2. 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.
3. 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.
4. Untreated and/or active brain metastases.
5. Prior therapies targeting poly (ADP-ribose) polymerase (PARP).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 5 patient groups

Phase 1: 20 milligram (mg) pamiparib

Experimental group

Description:

20 mg pamiparib twice a day for 21 days

Treatment:

Drug: Pamiparib

Phase 1 : 40 mg pamiparib

Experimental group

Description:

40 mg pamiparib twice a day for 21 days

Treatment:

Drug: Pamiparib

60 mg pamiparib

Experimental group

Description:

60 mg pamiparib twice a day for 21 days

Treatment:

Drug: Pamiparib

60 mg pamiparib in platinum-sensitive ovarian cancer (PSOC)

Experimental group

Description:

60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion

Treatment:

Drug: Pamiparib

60 mg pamiparib in platinum resistant ovarian cancer (PROC)

Experimental group

Description:

60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion

Treatment:

Drug: Pamiparib