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The Study of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor

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: NCT03641586
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetics, food effect, and preliminary antitumor activities of BGB-283 in Chinese subjects with local advanced or metastatic malignant solid tumor.

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

Detailed Description:

"This study is conducted on the basis of the completed multi-dose, dose escalation, Phase IA trial in Australia, is a dose-finding, dose expansion and food effects study of BGB-283 capsules in Chinese patients with locally advanced or metastatic solid tumor to determine the tolerability, safety, pharmacokinetic profiles, preliminary efficacy, food effects under high-fat meal on the absorption and metabolism of BGB-283, and preliminary anti-tumor efficacy.

The study was conducted in three phases: Stage I for dose escalation, Stage II for dose expansion and Stage III for food effects on pharmacokinetics under high fat meal.

Stage I Dose escalation: In a open-label, dose-escalation design, dose escalation will be performed with the '3 + 3' scheme and the dosage levels of BGB-283 capsules will be gradually increased.

Stage II Dose expansion: 20 mg/qd and 30 mg/qd are considered as effective and safe doses, based on preliminary results from Phase IA clinical studies in Australia. To further understand the preliminary pharmacodynamic results of BGB-283 in Chinese patients with malignant melanoma, 20mg/qd dose expansion study in B-RAF mutated malignant melanoma will be further explored if it has been proved to be a safe dose in Chinese population according to the '3 + 3' scheme.

Stage III uses multi-center, open, two-group crossover self-control design to compare the high-fat meal effect on pharmacokinetics."

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single and Multiple Dose Escalation/Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Food Effect, and Preliminary Antitumor Activities of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor
Actual Study Start Date : October 12, 2015
Actual Primary Completion Date : December 6, 2016
Actual Study Completion Date : March 7, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Stage I
Approximately 25-35 Chinese subjects with local advanced or metastatic malignant solid tumor will be enrolled in the dose escalation stage of BGB-283 until maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) determination
 Drug: BGB-283
Experimental: Stage II
Approximately 15-30 melanoma subjects will be enrolled in dose expansion stage of BGB-283
 Drug: BGB-283
Experimental: Stage III
20 subjects will be enrolled for food effect stage of BGB-283
 Drug: BGB-283


Outcome Measures
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Primary Outcome Measures :
  1. Stage 1: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average [ Time Frame: From signing the informed consent form and throughout the study, 1 year in average ]
  2. Stage 2: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1 [ 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, 1 year in average ]
  3. Stage 3: Area under the plasma concentration-time curve from time 0 to infinity time (AUC) [ Time Frame: Within 43 days since first dose ]
  4. Stage 3: Maximum plasma concentration (Cmax) [ Time Frame: Within 43 days since first dose ]
  5. Stage 3: Terminal elimination half-life (t1/2) [ Time Frame: Within 43 days since first dose ]
  6. Stage 3: Detect Ka for Pop-PK analysis [ Time Frame: Within 43 days since first dose ]
  7. Stage 3: Detect CL/F for Pop-PK analysis [ Time Frame: Within 43 days since first dose ]
  8. Stage 3: Detect Vc/F for Pop-PK analysis [ Time Frame: Within 43 days since first dose ]

Secondary Outcome Measures :
  1. Stage 1: Area under the plasma concentration-time curve from time 0 to infinity time (AUC) [ Time Frame: Within 43 days since first dose ]
  2. Stage 1: Maximum plasma concentration (Cmax) [ Time Frame: Within 43 days since first dose ]
  3. Stage 1: Terminal elimination half-life (t1/2) [ Time Frame: Within 43 days since first dose ]
  4. Stage 1: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1 [ 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, 1 year in average ]
  5. Stage 2: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average [ Time Frame: From signing the informed consent form and throughout the study, 1 year in average ]
  6. Stage 3: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1 [ 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, 1 year in average ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (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 between 18 and 75 years old.
  3. A life expectancy of more than 12 weeks.
  4. Stage I and III: Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available. We simultaneously require patients with one of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
  5. In Stage II: we require advanced or metastatic melanoma with the B-RAF mutation.
  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 > 90 g/L
    • Absolute neutrophil count ≥ 1.5x10^9/L
    • Platelets ≥ 100 x10^9/L
    • 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 ≥ 50 mL/min (calculated by the Cockcroft Gault formula).

Exclusion Criteria:

  1. Female subjects who are pregnant or lactating.
  2. Prior chemotherapy, radiotherapy, immunotherapy or any investigational therapies used to control cancer must have been completed at least 4 weeks or at least 5 half-lives (whichever is shorter before study drug administration, but at least 21 days)
  3. Any major surgery within 28 days prior to enrollment.
  4. Any radiotherapy for metastatic foci within 14 days prior to enrollment,
  5. Unresolved toxicity > Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy.
  6. History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
  7. Any clinical significant active infection that need systematic treatment, including HIV positive subjects, or known Hepatitis B or C.
Contacts and Locations
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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): NCT03641586


Locations
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China
Beijing Cancer Hospital
Beijing, China
Beijing Cancer Hosptial
Beijing, China
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Xiang Li, MD BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03641586    
Other Study ID Numbers: BGB-283-CN-001
CTR20150575 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: May 2019
Keywords provided by BeiGene:
Dose Escalation
Dose Expansion
BGB-283
Additional relevant MeSH terms:
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Neoplasms