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

NCT03333915 | Completed Phase 1 Results

• 2 other identifiers: BGB-290-102CTR20160828
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Advanced High-grade Ovarian Cancer; Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

  A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment).

  From first dose to within 30 days of last dose of pamiparib (approximately 36 months)

• Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)

  From first dose to within 30 days of last dose of pamiparib (approximately 36 months)

• Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)

  ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response

  Up to approximately 2 years and 8 months

Secondary Outcomes (23)

• Phase I: Maximum Observed Plasma Concentration (Cmax)

  Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

• Phase I: Time to Reach Cmax (Tmax)

  Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

• Phase I: Terminal Elimination Half-life (t1/2)

  Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

• Phase I: Apparent Clearance (CL/F)

  Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

• Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)

  Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose

Study Arms (5)

Phase 1: 20 milligram (mg) pamiparib

EXPERIMENTAL

20 mg pamiparib twice a day for 21 days

Drug: Pamiparib

Phase 1 : 40 mg pamiparib

EXPERIMENTAL

40 mg pamiparib twice a day for 21 days

Drug: Pamiparib

60 mg pamiparib

EXPERIMENTAL

60 mg pamiparib twice a day for 21 days

Drug: Pamiparib

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

EXPERIMENTAL

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

Drug: Pamiparib

60 mg pamiparib in platinum resistant ovarian cancer (PROC)

EXPERIMENTAL

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

Drug: Pamiparib

Interventions

Pamiparib DRUG

Pamiparib is provided as oral capsules

Also known as: BGB-290

60 mg pamiparib; 60 mg pamiparib in platinum resistant ovarian cancer (PROC); 60 mg pamiparib in platinum-sensitive ovarian cancer (PSOC); Phase 1 : 40 mg pamiparib; Phase 1: 20 milligram (mg) pamiparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \) 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.
• \. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

You may not qualify if:

• 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).

Sponsors & Collaborators

• BeiGene: lead

Study Sites (6)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

pamiparib

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 7, 2017
• Study Start: December 21, 2016
• Primary Completion: August 24, 2020
• Study Completion: August 11, 2021
• Last Updated: February 4, 2025
• Results First Posted: February 22, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)