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

NCT ID: NCT01863485

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

Brief 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.

Detailed Description

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. After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of ~20 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CM082

CM082 tablet

Group Type: EXPERIMENTAL

CM082 Tablet

Intervention Type: DRUG

CM082 tablets taken orally once a day on 28-day cycles

Interventions

CM082 Tablet

CM082 tablets taken orally once a day on 28-day cycles

Intervention Type: DRUG

Other Intervention Names

X-82

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

AnewPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin-Wan Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

Locations

Beijing University First Hospital

Beijing, Beijing Municipality, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Other Identifiers

2013L00579、2013L00581

Identifier Type: OTHER

Identifier Source: secondary_id

CM082-CA-I-001

Identifier Type: -

Identifier Source: org_study_id