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Trial record 1 of 1 for:    NCT02361723
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Phase 1A/1B BGB-290 for Advanced Solid Tumors.

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ClinicalTrials.gov Identifier: NCT02361723
Recruitment Status : Active, not recruiting
First Posted : February 12, 2015
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

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 subjects 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 subjects 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 subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
For Patients With Advanced Solid Tumors Failed With Previous Lines of Treatment Drug: BGB-290 Phase 1

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 subjects 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 subjects 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 subjects with advanced solid tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: ovarian cancer, fallopian cancer, or primary peritoneal cancer
60mg BID oral.
Drug: BGB-290
Experimental: Breast Cancer
60mg BID Ora
Drug: BGB-290
Experimental: Prostate Cancer
60mg BID Oral
Drug: BGB-290
Experimental: Small Cell Lung Cancer
60mg BID Oral
Drug: BGB-290
Experimental: Gastric Cancer
60mg BID Oral
Drug: BGB-290



Primary Outcome Measures :
  1. Objective response rate ([ORR]: CR + 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.

  2. PSA response (for prostate cancer subjects only) based on 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.

  3. Primary PK 1 [ Time Frame: through study completion, an average of 1 year ]
    Primary PK parameter is AUClast.

  4. Primary PK 2 [ Time Frame: through study completion, an average of 1 year ]
    Primary PK parameter is AUC.

  5. Primary PK 3 [ Time Frame: through study completion, an average of 1 year ]
    Primary PK parameter is Cmax.


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: through study completion, an average of 1 year ]
    Subjects, who are withdrawn from the study without documented progression, will be censored at the date of the last tumor assessment when the subject was known to be progression free. Subjects without post screening tumor assessments, but known to be alive will be censored at the time of the first administration of BGB 290).

  2. Duration of response for responders (CR or PR) and duration of SD (defined only for subjects whose confirmed best response is CR, PR, or SD. [ Time Frame: through study completion, an average of 1 year ]
    For subjects 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).

  3. The number and proportion of subjects 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 subjects, tumor responses may also be evaluated using RECIST Version 1.1 combined with CA-125 based on the GCIG criteria. For subjects with prostate cancer, PCWG2 criteria may be used to evaluate responses by investigators.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 subject population is permitted.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  5. Adequate bone marrow, liver, and renal function.
  6. Subjects who have histologic or cytologic confirmation of malignancy that has progressed to the advanced or metastatic stage.
  7. Eligible subjects who have received the prior chemotherapy regimen in the advanced or metastatic setting.
  8. Female subjects 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. Subjects did not receive prior therapies targeting PARP.
  2. Subjects 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. Subjects 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. Subjects who have not undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit.
  5. Subjects must have recovered from the treatment and have a stable clinical condition before entering this study.
  6. Subjects who have not received therapeutic radiotherapy to target lesions. 7.Subjects 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361723


Locations
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Australia, New South Wales
Gosford Hospital
Hamlyn Terrace, New South Wales, Australia, NSW 2559
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, SA 5042
Australia, Victoria
Austin Health Joint Ludwig/Oncology Unit
Heidelberg, Victoria, Australia, VIC 3084
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, VIC 3000
Nucleus Network
Melbourne, Victoria, Australia, VIC 3004
Australia, Western Australia
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Michael Millward Linear Clinical Research

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT02361723     History of Changes
Other Study ID Numbers: BGB-290-AU-002
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BeiGene:
Advanced Solid Tumors

Additional relevant MeSH terms:
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Neoplasms