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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006440-19 | EudraCT Number |
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This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| once weekly dosing schedule | Experimental |
| |
| twice weekly dosing schedule | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSP990 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of HSP990 in patients treated once weekly or twice weekly | At the end of the dose escalation phase of the study |
| Measure | Description | Time Frame |
|---|---|---|
| True DLT rate | At the end of the 1st 4 weeks of treatment | |
| Preliminary Efficacy | Every 2 months (or 8 weeks, which equals 2 treatment cycles) | |
| Drug metabolism in Humans, PK, PD |
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Inclusion Criteria:
Exclusion Criteria:
Patients with present or history of CNS metastasis.
Prior treatment with any Hsp90 or HDAC inhibitor compound.
Patients who have not recovered from side effects of previous systemic anticancer therapy to < CTCAE Grade 2 prior to the first dose
Patients identified to be "poor or intermediate CYP2C9 metabolizers"
Patients who received systemic anti-cancer treatment prior to the first dose of HSP990 within the following time frames:
Treatment with therapeutic doses of sodium warfarin (Coumadin).
Patients using medications that are CYP2C9 inhibitors and/or medications known to have QT prolongation effect and cannot be switched or discontinued to an alternative drug prior to commencing HSP990 dosing.
Unresolved diarrhea ≥ CTCAE grade 2
Patients who do not have either an archival tumor sample available or readily obtainable in the course of the study or are unwilling to have a fresh tumor sample collected at baseline.
Pregnant or lactating women.
Fertile women of childbearing potential (WCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile). Male patients whose partners are WCBP, not using adequate contraception.
Acute or chronic liver disease.
Acute or chronic renal disease.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of HSP990
Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
Known diagnosis of HIV infection (HIV testing is not mandatory).
Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
Cardiac exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CHSP990A2101 can be found on the Novartis Clinical Trials Results Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C570862 | 2-amino-7-(4-fluoro-2-(6-methoxypyridin-2-yl)phenyl)-4-methyl-7,8-dihydropyrido(4,3-d)pyrimidin-5(6H)-one |
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| every 4 weeks |
| Toulouse |
| 31052 |
| France |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |