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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

NCT ID: NCT03150810

Last Updated: 2024-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2023-05-04

Brief Summary

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The primary objective of this study was 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.

Detailed Description

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Conditions

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Locally Advanced or Metastatic Solid Tumors

Keywords

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Ovarian cancer Triple negative breast cancer Small cell lung cancer Gastric cancer temozolomide BGB-290 antineoplastic agents alkylating, alkylating agents, Poly (ADP-ribose) polymerase inhibitors enzyme inhibitors Head and neck cancer Esophageal cancer Soft tissue sarcoma Non small cell lung cancer pamiparib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 milligrams (mg) (Days 1-7)

Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)

Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)

Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)

Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)

Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)

Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)

Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)

Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Expansion: Gastric Cancer

Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Expansion: Ovarian Cancer

Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Expansion: SCLC

Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Expansion: TNBC

Participants with triple negative breast cancer (TNBC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Dose Expansion: Other HRD+ Cancers

Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

Group Type EXPERIMENTAL

Pamiparib

Intervention Type DRUG

Administered by mouth as a capsule twice daily

Temozolomide

Intervention Type DRUG

TMZ at various doses administered by mouth as a capsule once daily.

Interventions

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Pamiparib

Administered by mouth as a capsule twice daily

Intervention Type DRUG

Temozolomide

TMZ at various doses administered by mouth as a capsule once daily.

Intervention Type DRUG

Other Intervention Names

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BGB-290 TMZ temodar

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years old with advanced or metastatic stage solid tumors
2. Eastern Cooperative Oncology Group (ECOG) status ≤ 1
3. Have disease either evaluable (dose-escalation cohort) or measurable (dose-escalation and -expansion cohorts) per RECIST V1.1, except for prostate cancer participants
4. Agree to provide archival tumor tissue

* Participants with homologous recombination deficiency (HRD+) or known BRCA mutant ovarian cancer Previously received at least one line of platinum-containing therapy in the advanced or metastatic setting and No progression or recurrent disease within 6 months from last platinum-containing regimen.
* Participants with HRD+ or known BRCA mutant triple-negative breast cancer Up to one prior platinum-containing treatment in any treatment setting and up to 3 prior lines of therapy in the advanced or metastatic setting
* Participants with HRD+ or known BRCA mutant prostate cancer Chemotherapy-naïve or previously received up to two taxane-based chemotherapy regimens, with documented prostate cancer progression
* Participants with small cell lung cancer and gastric cancer, previously received ≤ 2 prior lines of therapy
* Other HRD+ solid tumors of multiple indications

Exclusion Criteria

1. Prior treatment with a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.
2. Refractory to platinum-based therapy (dose-expansion cohort).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myriad Genetics, Inc.

INDUSTRY

Sponsor Role collaborator

BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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Start Midwest

Grand Rapids, Michigan, United States

Site Status

Washington University in St Louis

St Louis, Missouri, United States

Site Status

Mount Sinai Prime

New York, New York, United States

Site Status

Montefiore Medical Park At Eastchester Einstein Campus

The Bronx, New York, United States

Site Status

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

Texas Oncology (Loop) Usor

Dallas, Texas, United States

Site Status

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Site Status

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia

Site Status

Saint Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Site Status

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Hospital Universitario Vall Dhebron

Barcelona, , Spain

Site Status

Ico H Duran I Reynals

Barcelona, , Spain

Site Status

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Site Status

Start Madrid Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Site Status

Hospital Universitario Virgen de La Macarena

Seville, , Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Site Status

Northern Centre For Cancer Care

High Heaton, , United Kingdom

Site Status

University College Hospital

London, , United Kingdom

Site Status

Sarah Cannon Research Institute Uk

London, , United Kingdom

Site Status

Countries

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United States Australia Spain United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-001553-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BGB-290-103

Identifier Type: -

Identifier Source: org_study_id