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Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02610361
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-283 in patients with solid tumours.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: BGB-283 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Intervention Model: Single Group 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 and Preliminary Antitumor Activities of the B RAF Inhibitor BGB 283 in Subjects With Solid Tumors
Study Start Date : November 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: BGB-283 Drug: BGB-283

In the dose escalation part(phase 1a): the dose levels will be escalated following a modified 3+3 dose escalation scheme.

In dose expansion phase(Phase 1b): Patients will be assigned to different groups based on their tumor types





Primary Outcome Measures :
  1. Number of participants with adverse events in phase 1a [ Time Frame: From first dose to within 28 days of last dose of BGB-283, within 1 years in average ]
  2. Objective response rate based on RECIST Version 1.1 in subjects with selected tumor types in phase 1b [ Time Frame: From the first administration of the investigational product to the end of the study treatment, within 1 year in average ]

Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) in phase 1a [ Time Frame: During first 2 weeks ]
  2. Area under the plasma concentration-time curve from time 0 to infinity time in (AUC∞) in phase 1a [ Time Frame: During first 2 weeks ]
  3. Maximum plasma concentration (Cmax) in phase 1a [ Time Frame: During first 2 weeks ]
  4. Time to reach maximum plasma concentration (tmax) in phase 1a [ Time Frame: During first 2 weeks ]
  5. Terminal elimination half-life (t1/2) in phase 1a [ Time Frame: During first 2 weeks ]
  6. Tumor response in phase 1a [ 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, within 1 year in average ]
  7. Number of participants with adverse events in phase 1b [ Time Frame: From first dose to within 28 days of last dose of BGB-283, within 1 year in average ]
  8. Progression-free survival (PFS) [ Time Frame: The interval from study treatment initiation until the determination of disease progression or death, within 1 year in average ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  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. One of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  7. Able to swallow and retain oral medication.
  8. Adequate bone marrow, liver, and renal function:

    • Hemoglobin > 9 g/dL
    • Absolute neutrophil count ≥ 1000/mm^3
    • Platelets ≥ 100,000/mm^3
    • Total bilirubin ≤1.5 times the upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with known liver metastasis)
    • Creatinine clearance ≥ 45 mL/min (calculated by the Cockcroft Gault formula).
  9. Female subjects are eligible to enter and participate in the study if they are of:

    a) Non childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who

    i) Has had a hysterectomy,

    ii) Has had a bilateral oophorectomy (ovariectomy),

    iii) Has had a bilateral tubal ligation, or

    iv) Is post menopausal (total cessation of menses for ≥ 1 year).

    b) Childbearing potential, has a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception before study entry and throughout the study until 28 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:

    i) Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.

    ii) Any intrauterine device with a documented failure rate of less than 1% per year.

    iii) Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.

  10. Subjects with treated brain metastasis are eligible to enter and participate in the study if they are neurologically stable.

Exclusion Criteria:

  1. Female subjects who are pregnant or lactating.
  2. Subjects receiving cancer therapy (chemotherapy or other systemic anti cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment.
  3. Any major surgery within 28 days prior to enrollment.
  4. Any radiotherapy within 14 days prior to enrollment, providing the subject has recovered from all toxicities to NCI-CTCAE ≤ Grade 1.
  5. Use of any investigational anti cancer drug within 28 days before the first investigational product administration.
  6. Unresolved toxicity > Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy, unless agreed by the sponsor.
  7. History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or to any component of BGB-283. (To date there are no known Food and Drug Administration [FDA] approved drugs chemically related to BGB-283).
  9. Untreated leptomeningeal or brain metastasis. Subjects with previously treated brain metastasis that are asymptomatic, off steroids for longer than 28 days are permitted.
  10. Any unstable, pre-existing major medical condition that in the opinion of the Investigator contra indicates the use of an investigational product, including active infection, known human immunodeficiency virus (HIV) positive subjects, or known Hepatitis B or C.
  11. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  12. As a result of the medical interview, physical examination or screening investigations, the investigator considers the subject unfit for study.
  13. Is on medication listed in the protocol or requires any of these medications during treatment with BGB-283.
  14. Candidates for curative therapy.
  15. Unable or unwilling to comply with the required treatment.

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): NCT02610361


Locations
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
North Coast Cancer Institute
Port Macquarie, New South Wales, Australia, 2444
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Tasman Oncology Research Ltd
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia, 3144
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Australia, Western Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia, 6009
New Zealand
Christchurch Hospital
Christchurch, New Zealand, 8011
Dunedin Public Hospital
Dunedin, New Zealand, 9106
Waikato Hospital
Hamilton, New Zealand
Wellington Hospital
Wellington, New Zealand
Sponsors and Collaborators
BeiGene

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT02610361     History of Changes
Other Study ID Numbers: BGB-283-AU-001
ACTRN12614001176651 ( Other Identifier: The Australian New Zealand Clinical Trials Registry )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018