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Trial record 2 of 22 for:    beigene

Study of the Safety and Pharmacokinetics of BGB-290 in Subjects With Solid Tumors

This study is currently recruiting participants.
Verified May 2017 by BeiGene
Sponsor:
ClinicalTrials.gov Identifier:
NCT02361723
First Posted: February 12, 2015
Last Update Posted: May 12, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Myriad Genetic Laboratories, Inc.
Information provided by (Responsible Party):
BeiGene
  Purpose
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-290 in patients with solid tumors.

Condition Intervention Phase
Solid Tumors Drug: BGB-290 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IA/IB, 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

Further study details as provided by BeiGene:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: From first dose to within 28 days of last dose of BGB-290 ]
  • Objective response rate [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 85
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGB-290 Drug: BGB-290
The dose levels will be escalated following a modified 3+3 dose escalation scheme.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Part IA:

  1. Provided written informed consent prior to enrollment.
  2. Male or female and at least 18 years of age.
  3. A life expectancy of at least 12 weeks.
  4. Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available.
  5. BRCA1/2 mutations are not required but enrichment of this subject population is permitted.
  6. Small cell lung cancer, high grade serous ovarian cancer, and triple negative breast cancer subjects will be preferentially recruited.
  7. Glioblastoma multiforme subjects may be eligible, after discussion between the sponsor and investigator.
  8. Archival tumor tissues are strongly recommended to be collected if available.
  9. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.

Phase IB/Part A:

  1. Provided written informed consent prior to screening visit.
  2. Male or female and at least 18 years of age on day of signing informed consent.
  3. Subjects who have histologically or cytologically confirmed advanced or metastatic ovarian, fallopian cancer, primary peritoneal cancer, breast cancer, or CRPC and have progressed after receiving at least one prior chemotherapy regimen in the advanced or metastatic setting could be recruited L
  4. Subjects must have measurable disease as defined per RECIST Version 1.1, except:

    1. Subjects with ovarian cancer without measurable disease may be considered if evaluable based on GCIG CA-125 criteria, after discussion with sponsor medical monitor.
    2. Subjects with metastatic CRPC (mCRPC) and with only non-measurable bone lesions must have either progression with 2 or more new lesions or have prostate-specific antigen (PSA) progression as specified by the PCWG2 criteria for study eligibility within the 6-week period before study drug administration.
  5. All subjects must agree to provide blood sample for germline BRCA and/or other mutation testing.
  6. ECOG performance status of ≤1.
  7. A life expectancy of at least 12 weeks.

Phase IB/Part B:

  1. Provided written informed consent prior to screening visit.
  2. Male or female and at least 18 years of age on day of signing informed consent.
  3. Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available.
  4. BRCA1/2 mutations are not required but enrichment of this subject population is preferable. Subjects with ovarian, fallopian, primary peritoneal, breast cancer or CRPC must agree to provide blood sample for germline BRCA and/or other mutation testing even if it has been previously tested.
  5. It is highly recommended that subjects provide archival tumor tissues or agree to a tumor biopsy for biomarker analysis
  6. Small cell lung cancer, high-grade serous ovarian cancer, and triple negative breast cancer subjects will be preferentially recruited.
  7. Subjects must have measurable disease as defined per RECIST Version 1.1. Subjects with ovarian cancer without measurable disease may be considered if evaluable based on GCIG CA 125 criteria, after discussion with sponsor medical monitor.
  8. ECOG performance status of ≤1.
  9. A life expectancy of at least 12 weeks.

Exclusion Criteria:

  1. Subjects who have been treated with chemotherapy, biologic therapy, immunotherapy, or other investigational agent within 5 t1/2 or within 4 weeks (whichever is longer) prior to starting study drug (or who have not recovered from the side effects of such therapy)
  2. Subjects who have undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit. subjects must have recovered from the treatment and have a stable clinical condition before entering this study
  3. Subjects who have received radiotherapy of target lesions
  4. Subjects who have received local radiotherapy of non-target lesions for local symptom control within the last 4 weeks must have recovered from any adverse effects of radiotherapy before recording baseline symptoms
  5. Lesions treated with locoregional therapies within the last 3 months before study inclusions do not qualify as target lesions unless progression was demonstrated
  Contacts and Locations
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


Contacts
Contact: Jason Yang, MD, PhD clinicaltrials@beigene.com

Locations
Australia, Victoria
Austin Health Hospital Recruiting
Heidelberg, Victoria, Australia
Nucleus Network Recruiting
Melbourne, Victoria, Australia
Australia, Western Australia
Linear Clinical Research/Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia
Sponsors and Collaborators
BeiGene
Myriad Genetic Laboratories, Inc.
Investigators
Study Director: Jason Yang, MD, PhD BeiGene
  More Information

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT02361723     History of Changes
Other Study ID Numbers: BGB-290-AU-002
First Submitted: January 29, 2015
First Posted: February 12, 2015
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided