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

• Status: Completed
• Trial end date: 2019-03-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

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.