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Sponsored by: |
Piramal Life Sciences Limited |
Information provided by: | Piramal Life Sciences Limited |
ClinicalTrials.gov Identifier: | NCT00408018 |
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 |
MedlinePlus related topics: | Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Multicentric Phase 1 Study of Selective Cyclin Dependent Kinase Inhibitor P276-00 in Patients With Advanced Refractory Neoplasms |
Estimated Enrollment: | 40 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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:
India, Andhra Pradesh | |||||
Nizam's Institute of Medicai Sciences | |||||
Hyderabaad, Andhra Pradesh, India, 500082 | |||||
Global Hospital | |||||
Hyderabad, Andhra Pradesh, India | |||||
India, Maharashtra | |||||
Tata Memorial Hospital | |||||
Mumbai, Maharashtra, India, 400012 |
Piramal Life Sciences Limited |
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 |
Responsible Party: | Piramal Life Sciences Limited ( Dr Himanshu Parikh ) |
Study ID Numbers: | P276-00/02/05 |
First Received: | December 4, 2006 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00408018 |
Health Authority: | India: Ministry of Health |
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