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

NCT03641586 | Completed Phase 1

• 2 other identifiers: BGB-283-CN-001CTR20150575
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

Dose Escalation; Dose Expansion; BGB-283

Outcome Measures

Primary Outcomes (8)

• Stage 1: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average

  From signing the informed consent form and throughout the study, 1 year in average

• Stage 2: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1

  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

• Stage 3: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)

  Within 43 days since first dose

• Stage 3: Maximum plasma concentration (Cmax)

  Within 43 days since first dose

• Stage 3: Terminal elimination half-life (t1/2)

  Within 43 days since first dose

• Stage 3: Detect Ka for Pop-PK analysis

  Within 43 days since first dose

• Stage 3: Detect CL/F for Pop-PK analysis

  Within 43 days since first dose

• Stage 3: Detect Vc/F for Pop-PK analysis

  Within 43 days since first dose

Secondary Outcomes (6)

• Stage 1: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)

  Within 43 days since first dose

• Stage 1: Maximum plasma concentration (Cmax)

  Within 43 days since first dose

• Stage 1: Terminal elimination half-life (t1/2)

  Within 43 days since first dose

• Stage 1: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1

  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

• Stage 2: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average

  From signing the informed consent form and throughout the study, 1 year in average

Study Arms (3)

Stage I

EXPERIMENTAL

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

Stage II

EXPERIMENTAL

Approximately 15-30 melanoma subjects will be enrolled in dose expansion stage of BGB-283

Drug: BGB-283

Stage III

EXPERIMENTAL

20 subjects will be enrolled for food effect stage of BGB-283

Drug: BGB-283

Interventions

BGB-283 DRUG

Stage I; Stage II; Stage III

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written informed consent prior to enrollment.
• Male or female and between 18 and 75 years old.
• A life expectancy of more than 12 weeks.
• 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.
• In Stage II: we require advanced or metastatic melanoma with the B-RAF mutation.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Able to swallow and retain oral medication.
• 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).

You may not qualify if:

• Female subjects who are pregnant or lactating.
• 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)
• Any major surgery within 28 days prior to enrollment.
• Any radiotherapy for metastatic foci within 14 days prior to enrollment,
• Unresolved toxicity \> Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy.
• History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Any clinical significant active infection that need systematic treatment, including HIV positive subjects, or known Hepatitis B or C.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

BGB-283

Study Officials

• Xiang Li, MD

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 22, 2018
• Study Start: October 12, 2015
• Primary Completion: December 6, 2016
• Study Completion: March 7, 2019
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

CN (1)