Clinical trial · Interventional
Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
Phase 1 Safety, Tolerability, and Pharmacokinetic Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
NCT01863485CI-TRIAL-00039322completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CM082 Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CM082
- description
- CM082 tablet
- interventionNames
- Drug: CM082 Tablet
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 12 months
- description
- To determine the Maximum Tolerated Dose in Chinese patients with advanced solid tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.