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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02361723
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE January 29, 2015
First Posted Date  ICMJE February 12, 2015
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE July 3, 2014
Actual Primary Completion Date September 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1 [ Time Frame: through study completion, an average of 1 year ]
    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.
  • Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria [ Time Frame: through study completion, an average of 1 year ]
    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.
  • Primary PK 1 [ Time Frame: through study completion, an average of 1 year ]
    Primary PK parameter is area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast).
  • Primary PK 2 [ Time Frame: through study completion, an average of 1 year ]
    Primary PK parameter is area under plasma concentration time curve (AUC).
  • Primary PK 3 [ Time Frame: through study completion, an average of 1 year ]
    Primary PK parameter is maximum observed plasma concentration (Cmax).
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2015)
Number of participants with adverse events [ Time Frame: From first dose to within 28 days of last dose of BGB-290 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • Progression free survival [ Time Frame: through study completion, an average of 1 year ]
    Participants, who are withdrawn from the study without documented progression, will be censored at the date of the last tumor assessment when the participant was known to be progression free. Participants without post screening tumor assessments, but known to be alive will be censored at the time of the first administration of BGB 290).
  • 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. [ Time Frame: through study completion, an average of 1 year ]
    For participants who are alive without progression following the qualifying response, duration of response will be censored on the date of last evaluable tumor assessment or last follow up for progression of disease).
  • The number and proportion of participants who achieve objective tumor response (complete response [CR], partial response [PR], and CR+PR) or stable disease (SD). [ Time Frame: through study completion, an average of 1 year ]
    For ovarian cancer participants, tumor responses may also be evaluated using RECIST Version 1.1 combined with CA-125 based on the Gynecologic Cancer Intergroup (GCIG) criteria. For participants with prostate cancer, PCWG2 criteria may be used to evaluate responses by investigators.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2015)
  • Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) [ Time Frame: During first 7 weeks ]
  • Area under the plasma concentration-time curve from time 0 to infinity time (AUC) [ Time Frame: During first 7 weeks ]
  • Maximum plasma concentration (Cmax) [ Time Frame: During first 7 weeks ]
  • Time to reach maximum plasma concentration (tmax) [ Time Frame: During first 7 weeks ]
  • Terminal elimination half-life (t1/2) [ Time Frame: During first 7 weeks ]
  • Tumor response [ Time Frame: Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months ]
  • PARP inhibition activity of BGB-290 by measurement of PAR [ Time Frame: During first 3 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1a/1b BGB-290 for Advanced Solid Tumors.
Official Title  ICMJE A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation, and Expansion Study to Investigate the Safety, Pharmacokinetics, Food Effect, and Antitumor Activities of BGB-290 in Subjects With Advanced Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment
Intervention  ICMJE Drug: BGB-290
Study Arms  ICMJE
  • Experimental: ovarian cancer, fallopian cancer, or primary peritoneal cancer
    60mg BID oral.
    Intervention: Drug: BGB-290
  • Experimental: Breast Cancer
    60mg BID Ora
    Intervention: Drug: BGB-290
  • Experimental: Prostate Cancer
    60mg BID Oral
    Intervention: Drug: BGB-290
  • Experimental: Small Cell Lung Cancer
    60mg BID Oral
    Intervention: Drug: BGB-290
  • Experimental: Gastric Cancer
    60mg BID Oral
    Intervention: Drug: BGB-290
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2020)
101
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2015)
30
Actual Study Completion Date  ICMJE September 3, 2019
Actual Primary Completion Date September 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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.

Key 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02361723
Other Study ID Numbers  ICMJE BGB-290-AU-002
2017-003646-25 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Millward, MD Linear Clinical Research
PRS Account BeiGene
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP