Status:
COMPLETED
Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
Lead Sponsor:
AnewPharma
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Advanced Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 (MT...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01863485
Start Date
May 1 2013
End Date
May 1 2016
Last Update
July 5 2019
Active Locations (3)
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1
Beijing University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
3
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021