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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The study will determine the maximum tolerated dose (MTD) of AUY922 given in combination with cetuximab in previously treated patients with KRAS wild-type metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AUY922 plus Cetuximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AUY922 | Drug | Weekly intravenous infusion on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of AUY922 is 40, 55, and 70 mg/m2 will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicity (DLT) | 1 cycle (1 cycle = 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient response rate to the AUY922. | After 2 years | |
| Time to tumor progression following treatment with AUY922. | After 2 years | |
| Overall survival of patients treated with AUY922. |
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Inclusion Criteria:
Exclusion Criteria:
Colorectal cancer with a KRAS mutation or in which the KRAS genotype status is unknown
Metastasis to the CNS
Prior treatment with any Hsp90 inhibitor compounds
Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
Treatment of therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2mg, for line patency permitted]
Known sensitivity to cetuximab
Unresolved ≥ grade 1 diarrhea
Malignant ascites that require invasive treatment
Concurrent medications that are substrates, inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 and cannot be switched or discontinued or switched to an alternative drug prior to commencing AUY922 dosing need special consideration on a case by case basis
Major surgery ≤ 2 weeks prior to randomization or who have not recovered from such therapy
Impaired cardiac function
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| Name | Affiliation | Role |
|---|---|---|
| Philip Gold, MD | Swedish Medical Center Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Medical Center Cancer Institute | Seattle | Washington | 98104 | United States |
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|
| Cetuximab | Drug | Cetuximab will be administered after each AUY922 infusion, intravenously on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression. |
|
| After 2 years |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C528044 | 5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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