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

NCT02361723 | Completed Phase 1

• 1 other identifier: BGB-290-AU-002
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1

  The primary endpoint of the study was a composite response rate that included ORR, a ≥50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.

  through study completion, an average of 1 year

• Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria

  The primary endpoint of the study was a composite response rate that included ORR, a ≥50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.

  through study completion, an average of 1 year

• Primary PK 1

  Primary PK parameter is area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast).

  through study completion, an average of 1 year

• Primary PK 2

  Primary PK parameter is area under plasma concentration time curve (AUC).

  through study completion, an average of 1 year

• Primary PK 3

  Primary PK parameter is maximum observed plasma concentration (Cmax).

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Progression free survival

  through study completion, an average of 1 year

• Duration of response for responders (CR or PR) and duration of SD (defined only for participants whose confirmed best response is CR, PR, or SD.

  through study completion, an average of 1 year

• The number and proportion of participants who achieve objective tumor response (complete response [CR], partial response [PR], and CR+PR) or stable disease (SD).

  through study completion, an average of 1 year

Study Arms (5)

ovarian cancer, fallopian cancer, or primary peritoneal cancer

EXPERIMENTAL

60mg BID oral.

Drug: BGB-290

Breast Cancer

EXPERIMENTAL

60mg BID Ora

Drug: BGB-290

Prostate Cancer

EXPERIMENTAL

60mg BID Oral

Drug: BGB-290

Small Cell Lung Cancer

EXPERIMENTAL

60mg BID Oral

Drug: BGB-290

Gastric Cancer

EXPERIMENTAL

60mg BID Oral

Drug: BGB-290

Interventions

BGB-290 DRUG

ovarian cancer, fallopian cancer, or primary peritoneal cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female and at least 18 years of age with a life expectancy of at least 12 weeks.
• Histologically or cytologically confirmed malignancy that has progressed to the advanced or metastatic stage for which no effective standard therapy is available.
• BRCA1/2 mutations are not required but enrichment of this participant population is permitted.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Adequate bone marrow, liver, and renal function.
• Participants who have histologic or cytologic confirmation of malignancy that has progressed to the advanced or metastatic stage.
• Eligible participants who have received the prior chemotherapy regimen in the advanced or metastatic setting.
• 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.
• Able to swallow and retain oral medication.

You may not qualify if:

• Participants did not receive prior therapies targeting poly-ADP ribose polymerase (PARP).
• 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).
• 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).
• Participants who have not undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit.
• Participants must have recovered from the treatment and have a stable clinical condition before entering this study.
• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (7)

Gosford Hospital

Gosford, New South Wales, 2250, Australia

Location

Cancer Care Wollongong

Wollongong, New South Wales, 2500, Australia

Location

Flinders Medical Centre

Bedford PK, South Australia, 5042, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (3)

• 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

  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.

  PMID: 34795408 DERIVED

• 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.

  PMID: 33128299 DERIVED

MeSH Terms

Interventions

pamiparib

Study Officials

• Michael Millward, MD

  Linear Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 12, 2015
• Study Start: July 3, 2014
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: December 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (7)