Trials / Completed
CompletedNCT00407498
Open Label Phase I Study of P276-00 in Patients With Advanced Refractory Neoplasms
An Open Label Multicentric Phase 1 Study of Selective Cyclin Dependent Kinase Inhibitor P276-00 in Patients With Advanced Refractory Neoplasms
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Piramal Enterprises Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
P276-00 is specific Cdk4-D1 and Cdk1-B inhibitor. P276-00 exhibited significant tumour reduction in animal models with less adverse effects.Based on the results from various in-vitro studies, P276-00 could be a potential candidate as a new mechanism based drug for the treatment of cancer.This Phase I study will determine the Maximum Tolerated Dose,Dose Limiting Toxicity and efficacy of P 276-00 in patients with advanced Refractory neoplasms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | P276-00 | Starting dose of 9 mg/m2/day from day 1to 5 and day 8 to 12 in 21 day cycle.Protocol wa amended to dose the subjects for day 1 to5 in 21 day cycle after 34.4 mg/m2/day cohort.Maximum dose administered was 259 mg/m2/day |
Timeline
- Start date
- 2005-05-01
- Primary completion
- 2008-03-01
- Completion
- 2008-09-01
- First posted
- 2006-12-05
- Last updated
- 2009-01-01
Locations
3 sites across 2 countries: Canada, India
Source: ClinicalTrials.gov record NCT00407498. Inclusion in this directory is not an endorsement.