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

Sponsor
BeiGene (Industry)
Overall Status
Completed
CT.gov ID
NCT02610361
Collaborator
(none)
131
Enrollment
20
Locations
1
Arm
46.4
Actual Duration (Months)
6.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
N/A
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
Actual Study Start Date :
Nov 20, 2013
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with adverse events in phase 1a [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 [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 [During first 2 weeks]

  2. Area under the plasma concentration-time curve from time 0 to infinity time in (AUC∞) in phase 1a [During first 2 weeks]

  3. Maximum plasma concentration (Cmax) in phase 1a [During first 2 weeks]

  4. Time to reach maximum plasma concentration (tmax) in phase 1a [During first 2 weeks]

  5. Terminal elimination half-life (t1/2) in phase 1a [During first 2 weeks]

  6. Tumor response in phase 1a [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 [From first dose to within 28 days of last dose of BGB-283, within 1 year in average]

  8. Progression-free survival (PFS) [The interval from study treatment initiation until the determination of disease progression or death, within 1 year in average]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

  1. Female subjects are eligible to enter and participate in the study if they are of:

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

  2. Has had a hysterectomy,

  1. Has had a bilateral oophorectomy (ovariectomy),

  2. Has had a bilateral tubal ligation, or

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

  1. 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:

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

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

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

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chris O'Brien Lifehouse Camperdown New South Wales Australia 2050
2 North Coast Cancer Institute Port Macquarie New South Wales Australia 2444
3 Prince of Wales Hospital Randwick New South Wales Australia 2031
4 Westmead Hospital Westmead New South Wales Australia 2145
5 Tasman Oncology Research Ltd Southport Queensland Australia 4215
6 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
7 Royal Adelaide Hospital Adelaide South Australia Australia 5000
8 The Queen Elizabeth Hospital Woodville South South Australia Australia 5011
9 Box Hill Hospital Box Hill Victoria Australia 3128
10 Monash Medical Centre Clayton Victoria Australia 3168
11 Austin Health Heidelberg Victoria Australia
12 Cabrini Hospital Malvern Victoria Australia 3144
13 The Alfred Hospital Melbourne Victoria Australia 3004
14 Peter MacCallum Cancer Centre Melbourne Victoria Australia
15 Royal Melbourne Hospital Parkville Victoria Australia
16 Linear Clinical Research Limited Nedlands Western Australia Australia 6009
17 Christchurch Hospital Christchurch New Zealand 8011
18 Dunedin Public Hospital Dunedin New Zealand 9106
19 Waikato Hospital Hamilton New Zealand
20 Wellington Hospital Wellington New Zealand

Sponsors and Collaborators

  • BeiGene

Investigators

  • Principal Investigator: Jayesh Desai, MD, Peter MacCallum Cancer Centre, Australia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT02610361
Other Study ID Numbers:
  • BGB-283-AU-001
  • ACTRN12614001176651
First Posted:
Nov 20, 2015
Last Update Posted:
Mar 25, 2020
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Mar 25, 2020