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| Sponsor: | Piramal Life Sciences Limited |
|---|---|
| Information provided by: | Piramal Life Sciences Limited |
| ClinicalTrials.gov Identifier: | NCT00408018 |
Purpose
P276-00 is a molecule derived from Rohitukine, which through pre clinical assays was identified as a selective Cdk4-D1 and Cdk1-B inhibitor.The inhibition of these Cdks causes cell cycle arrest between the G1-S transition thus blocking the cell cycle events at an early stage of development. It therefore has the potential for being efficacious with lesser side effects.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasm |
Drug: P276-00 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Multicentric Phase 1 Study of Selective Cyclin Dependent Kinase Inhibitor P276-00 in Patients With Advanced Refractory Neoplasms |
| Enrollment: | 28 |
| Study Start Date: | March 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Contacts and Locations| India | |
| Nizam's Institute of Medicai Sciences | |
| Hyderabaad, Andhra Pradesh, India, 500082 | |
| Global Hospital | |
| Hyderabad, Andhra Pradesh, India | |
| Tata Memorial Hospital | |
| Mumbai, Maharashtra, India, 400012 | |
| Principal Investigator: | Purvish M parikh, MD, DNB, PhD | Tata Memorial Hospital |
| Principal Investigator: | Raghunadharao D, MD, DM | Nizam's Institute of Medical Sciences |
| Principal Investigator: | Ravikumar Saxena, MD | Global Hospital |
More Information
| Responsible Party: | Dr Himanshu Parikh, Piramal Life Sciences Limited |
| ClinicalTrials.gov Identifier: | NCT00408018 History of Changes |
| Other Study ID Numbers: | P276-00/02/05 |
| Study First Received: | December 4, 2006 |
| Last Updated: | December 31, 2008 |
| Health Authority: | India: Ministry of Health |
|
Neoplasms Cyclin-Dependent Kinase Inhibitor Proteins Protein Kinase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |