Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.

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

Details

• Lead Sponsor: AnewPharma
• Collaborator: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Treatments: Vorolanib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.

• Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.

• Life expectancy of at least 12 weeks.

• No immuno deficiency.

• Adequate organ system function, defined as follows:

• Absolute neutrophil count (ANC) ≥1.5 x 10**9/L

• Platelets ≥100 x 10**9/L

• Hemoglobin ≥10 g/dL

• Total bilirubin ≤1.5 times the upper limit of normal (ULN)

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤2.5x the upper limit of normal with liver involvement.

• Creatinine ≤ 1.5 x ULN.

• At least 4 weeks or 5 half-life after receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization.

• Willingness and ability to comply with trial and follow-up procedures.

• Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

• Not recovered from prior anti-cancer therapy or surgery.

• Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks.

• Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes.

• Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).

• Females who are pregnant or breastfeeding.

• Those in reproductive ages who refuse to use contraception.

• Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol.

• Patients with known central nervous system (CNS) metastases.

• Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 (X-82).

• Patients with known GI disorders such as vomiting, diarrhea.

• Patients who are hepatitis B virus positive.

• Drug abuser.