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Sponsored by: |
Piramal Life Sciences Limited |
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Information provided by: | Piramal Life Sciences Limited |
ClinicalTrials.gov Identifier: | NCT00772876 |
This is a phase I study of a novel compound P1446A-05. Aim of this study is to identify the the recommended phase II dose of the drug and to determine the nature of adverse effects associated with the drug. P1446A-05 capsules will be given continuously (28 days in each 28 day cycle) to patients suffering from advanced malignancies with no effective treatment available. The dose of the study agent will be lower i.e. 75 mg per day for initial patients. If this dose is found safe, higher dose will be administered to next set of (three to six) patients. This will continued till the safest and best dose is identified. Treatment will be given for 4 cycles and continued further if found effective. Dose schedule may be modified to introduce treatment holiday,if frequent adverse effects are seen on continuous administration.
Condition | Intervention | Phase |
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Cancer |
Drug: P1446A-05 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Multicenter Phase I Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies |
Estimated Enrollment: | 52 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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P1446A-05: Experimental
Single arm of the study drug. This being a dose escalation study, patient will receive a dose depending on the stage of the trial.
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Drug: P1446A-05
P1446A-05 capsules will be given once daily for 28 days in each 28 day cycle for 4 such cycles. The starting dose, for first cohort will be 75 mg once daily. Subsequent cohorts of patients will receive higher doses till the recommended phase II dose is identified.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hemoglobin >/= 90 g/L Leukocytes >/=3 x 109/L Absolute Neutrophil Count (ANC) >/=1.5 x 109/L Platelets >/=100 x 109/L Total bilirubin </= 1.5 X institutional Upper Limit of Normal (ULN) AST(SGOT) </=2.5 X institutional ULN ALT(SGPT) </=2.5 X institutional ULN Creatinine </=1.5 X institutional ULN
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
Canada, Alberta | |
Cross Cancer Institute (CCI), | Recruiting |
Edmonton,, Alberta, Canada, T6G 1Z2 | |
Contact: Qincy Chu (780)432-8248 quincchu@cancerboard.ab.ca | |
Principal Investigator: Q Chu, MD, FRCP(C) | |
Canada, British Columbia | |
British Columbia Cancer Agency (BCCA), | Not yet recruiting |
Vancouver,, British Columbia, Canada, BC V5Z 4E6 | |
Contact: C Kollmannsberger, MD 604-877-6000 ext 2674 ckollmannsberger@bccancer.bc.ca | |
Principal Investigator: C Kollmannsberger, MD | |
Canada, Ontario | |
London Health Sciences Centre (LHSC) | Not yet recruiting |
London, Ontario, Canada, ON N6A 4L6 | |
Contact: S Welch (519) 685-8640 stephen.welch@lhsc.on.ca | |
Principal Investigator: S Welch |
Principal Investigator: | Siu-Chung Q Chu, MD, FRCP(C) | Staff Medical Oncologist, Cross Cancer Institute, Department of Medical Oncology, Edmonton, AB |
Principal Investigator: | Christian K Kollmannsberger, MD | Medical Oncologist, Division Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, BC |
Principal Investigator: | S Welch | London Health Sciences Centre (LHSC), London, Ontario |
Responsible Party: | Piramal Life Sciences Limited ( Dr. Himanshu Parikh, Vice President, Clinical Research (R & D) ) |
Study ID Numbers: | P1446A-05/20/08 |
Study First Received: | October 13, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00772876 |
Health Authority: | Canada: Health Canada; India: Drugs Controller General of India |
P1446A-05 Advanced refractory malignancies Phase I |
Cyclin-Dependent Kinase Inhibitor Proteins |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |