Trials / Completed
CompletedNCT01863485
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- AnewPharma · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CM082 Tablet | CM082 tablets taken orally once a day on 28-day cycles |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2014-10-01
- Completion
- 2016-05-01
- First posted
- 2013-05-29
- Last updated
- 2019-07-05
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01863485. Inclusion in this directory is not an endorsement.