drugset / Trial / NCT00407498
Open Label Phase I Study of P276-00 in Patients With Advanced Refractory Neoplasms
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-05
- Primary completion
- 2008-03
- Completion
- 2008-09
Publications
- Results Hirte H.W, Raghunatharao D, Baetz S, Hotte J, Rajappa S, Iaccobucci A, Sharma S, Parikh H, Kulkarni S, Patil S, Padigaru M, Gaston S. A Phase I study of the selective cyclin dependant kinase inhibitor P276-00 in Patients with advanced refractory neoplasms. AACR 2007 Abstract number #802
- Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P276-00 | Small molecule | 9 mg/m2 | — |
| Subject | P276-00 | Small molecule | 34.4 mg/m2 | — |
| Subject | P276-00 | Small molecule | 259 mg/m2 | — |