Phase 1a/1b BGB-290 for Advanced Solid Tumors.

NCT ID: NCT02361723

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-03
• Study Completion Date: 2019-09-03

Brief Summary

The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the Pharmacokinetics (PK) of BGB 290 in participants with advanced solid tumors.

Detailed Description

The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the PK of BGB 290 in participants with advanced solid tumors.

Conditions

For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment

Keywords

Advanced Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ovarian cancer, fallopian cancer, or primary peritoneal cancer

60mg BID oral.

Group Type: EXPERIMENTAL

BGB-290

Intervention Type: DRUG

Breast Cancer

60mg BID Ora

Group Type: EXPERIMENTAL

BGB-290

Intervention Type: DRUG

Prostate Cancer

60mg BID Oral

Group Type: EXPERIMENTAL

BGB-290

Intervention Type: DRUG

Small Cell Lung Cancer

60mg BID Oral

Group Type: EXPERIMENTAL

BGB-290

Intervention Type: DRUG

Gastric Cancer

60mg BID Oral

Group Type: EXPERIMENTAL

BGB-290

Intervention Type: DRUG

Interventions

BGB-290

Intervention Type: DRUG

BGB-290

Intervention Type: DRUG

BGB-290

Intervention Type: DRUG

BGB-290

Intervention Type: DRUG

BGB-290

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female and at least 18 years of age with a life expectancy of at least 12 weeks.

2. Histologically or cytologically confirmed malignancy that has progressed to the advanced or metastatic stage for which no effective standard therapy is available.

3. BRCA1/2 mutations are not required but enrichment of this participant population is permitted.

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

5. Adequate bone marrow, liver, and renal function.

6. Participants who have histologic or cytologic confirmation of malignancy that has progressed to the advanced or metastatic stage.

7. Eligible participants who have received the prior chemotherapy regimen in the advanced or metastatic setting.

8. Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and throughout the study until 28 days after the last investigational product administration.

9. Able to swallow and retain oral medication.

Exclusion Criteria

1. Participants did not receive prior therapies targeting poly-ADP ribose polymerase (PARP).

2. Participants who are not considered to be refractory to platinum-based therapy (e.g., progressive disease at the first tumor assessment while receiving platinum treatment).

3. Participants who have not been treated with chemotherapy, biologic therapy, immunotherapy, or other investigational agent within five times half-lives of the last treatment or within 4 weeks (whichever is longer) prior to starting study drug (or who have not recovered from the side effects of such therapy).

4. Participants who have not undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit.

5. Participants must have recovered from the treatment and have a stable clinical condition before entering this study.

6. Participants who have not received therapeutic radiotherapy to target lesions. 7.Participants who have received local palliative radiotherapy of non-target lesions for local symptom control within the last 21 days must have recovered from any adverse effects of radiotherapy before recording screening symptoms. 8.No untreated brain metastasis or unstable neurologic condition after the completion of radiation, or requiring corticosteroid of > 40 mg prednisone daily equivalent dose to control the symptoms.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Millward, MD

Role: PRINCIPAL_INVESTIGATOR

Linear Clinical Research

Locations

Gosford Hospital

Gosford, New South Wales, Australia

Cancer Care Wollongong

Wollongong, New South Wales, Australia

Flinders Medical Centre

Bedford PK, South Australia, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Nucleus Network

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Countries

Australia

References

Lickliter JD, Gan HK, Meniawy T, Yang J, Wang L, Luo LS, Millward M. A phase I dose-escalation study of BGB-290, a novel PARP1/2 selective inhibitor in patients with advanced solid tumors. Journal of Clinical Oncology. 2016; 34(15): DOI: 10.1200/JCO.2016.34.15_suppl.e17049

Reference Type: RESULT

Lickliter JD, Voskoboynik M, Mileshkin L, Gan HK, Kichenadasse G, Zhang K, Zhang M, Tang Z, Millward M. Phase 1A/1B dose-escalation and -expansion study to evaluate the safety, pharmacokinetics, food effects and antitumor activity of pamiparib in advanced solid tumours. Br J Cancer. 2022 Mar;126(4):576-585. doi: 10.1038/s41416-021-01632-2. Epub 2021 Nov 18.

Reference Type: DERIVED

PMID: 34795408 (View on PubMed)

Xu B, Yin Y, Dong M, Song Y, Li W, Huang X, Wang T, He J, Mu X, Li L, Mu S, Zhang W, Li M. Pamiparib dose escalation in Chinese patients with non-mucinous high-grade ovarian cancer or advanced triple-negative breast cancer. Cancer Med. 2021 Jan;10(1):109-118. doi: 10.1002/cam4.3575. Epub 2020 Oct 31.

Reference Type: DERIVED

PMID: 33128299 (View on PubMed)

Other Identifiers

BGB-290-AU-002

Identifier Type: -

Identifier Source: org_study_id