Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

Locally Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150810
• Other study ID #: BGB-290-103
• Secondary ID: 2017-001553-14
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 28, 2017
• Est. completion date: May 4, 2023

Study information

• Verified date: May 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Key Inclusion Criteria:

1. Age =18 years old with advanced or metastatic stage solid tumors

2. Eastern Cooperative Oncology Group (ECOG) status = 1 and measurable disease per RECIST V1.1 (except for participants in dose escalation and prostate cancer participants)

3. Additional inclusion criteria for dose expansion cohorts:

Participants with homologous recombination deficiency (HRD+) or known BRCA mutant Ovarian cancer a. Previously received at least 1 line of platinum containing chemotherapy and No progression or recurrent disease in 6 months from last platinum containing regimen. Participants with HRD+ or known breast cancer susceptibility gene (BRCA) mutant Triple-Negative Breast Cancer a. 0 - 1 prior platinum-containing regimen (any treatment setting) and received = 3 prior regimens (advanced or metastatic setting). Participants with HRD+ or known BRCA mutant Prostate cancer

1. Chemotherapy-naïve or previously received =2 taxane-based regimens.

2. May have pre-or post-treatment with a novel androgen receptor targeted agent. Participants Small cell lung and gastric cancer a. Previously received = 2 prior lines of therapy. Participants with HRD+ NSCLC, head and neck cancer, esophageal cancer and soft tissue sarcomas

1. Must have tumors with with HRD+ as centrally determined

2. Must have received at least 1 but not more than 3 prior lines of therapy. Treatment naïve patients with soft tissue sarcoma might be allowed if standard of care therapy is not suitable or available. Key Exclusion Criteria: All participants

1. Prior exposure to a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.

2. Refractory to platinum-based therapy. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• Pamiparib
60 mg (20 mg capsules) administered orally twice a day
• Temozolomide
Doses of up to 120 mg (as 20 mg capsules) administered orally once daily (QD) as specified in the treatment arm

Locations

Country	Name	City	State
Australia	Icon Cancer Centre Wesley	Auchenflower	Queensland
Australia	Icon Cancer Centre Chermside	Chermside	Queensland
Australia	Saint Vincent's Hospital	Darlinghurst	New South Wales
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Icon Cancer Centre North Lakes	North Lakes	Queensland
Australia	Icon Cancer Centre South Brisbane	South Brisbane	Queensland
Australia	Icon Cancer Centre Southport	Southport	Queensland
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Institut Catalia d'oncologia- l'Hospitalet	Barcelona
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	START Madrid-Fundación Jiménez Díaz	Madrid
Spain	START-Madrid	Madrid
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital Clínico de Valencia	Valencia
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Strathclyde
United Kingdom	Sarah Cannon Research Institute UK	London	Greater London
United Kingdom	Sir Bobby Robson Cancer Trials Research Centre	Newcastle	Newcastle Upon Tyne
United States	Mary Crowley Cancer Research Centers	Dallas	Texas
United States	University of Texas- MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute (Tennessee Oncology)	Nashville	Tennessee
United States	Montefiore Medical Center PRIME	New York	New York
United States	Mount Sinai - PRIME	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
BeiGene	Myriad Genetics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose limiting toxicities (DLTs) as assessed by CTCAE.		From first dose BGB-290 and TMZ to 28 days post-dosing
Primary	Number of participants experiencing Adverse Events (AEs)		From first dose BGB-290 and TMZ to 30 days post-dosing
Primary	Number of participants experiencing Severe Adverse Events (SAEs)		From first dose BGB-290 and TMZ to 30 days post-dosing
Primary	Objective Response Rate (ORR)		From first dose BGB-290 and TMZ to first documentation of disease progression, assessed up to 5 years
Secondary	maximum observed plasma concentration (Cmax) of BGB-290 and TMZ.		From first dose BGB-290 and TMZ to 30 days post-dosing
Secondary	lowest concentration reached before the next dose administered (Ctrough) of BGB-290 and TMZ.		From first dose BGB-290 and TMZ to 30 days post-dosing
Secondary	time to reach maximum (peak) plasma concentration (Tmax) of BGB-290 and TMZ.		From first dose BGB-290 and TMZ to 30 days post-dosing
Secondary	Duration of response (DOR).		From first dose BGB-290 and TMZ to first documentation of disease progression, assessed up to 5 years
Secondary	Disease control rate (DCR)		From first dose BGB-290 and TMZ to first documentation of disease progression while participant is alive, assessed to up 5 years
Secondary	Progression free survival (PFS)		From first dose BGB-290 and TMZ to first documentation of disease progression or death, whichever is first, assessed up to 5 years
Secondary	Overall survival (OS)		From first dose BGB-290 and TMZ until date of death, assessed up to 5 years