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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P1446A-05 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose Limiting Toxicities at a dose level | Cycle 1 of each subject |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | At the end of every 2 cycles |
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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 \
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Dr. Patricia Tang | Tom Baker Cancer Centre, Calgary, Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | T4N4N2 | Canada | ||
| Cross Cancer Institute (CCI), |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19238148 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| Edmonton |
| Alberta |
| T6G 1Z2 |
| Canada |
| British Columbia Cancer Agency (BCCA), | Vancouver | British Columbia | BC V5Z 4E6 | Canada |
| London Health Sciences Centre (LHSC) | London | Ontario | ON N6A 4L6 | Canada |