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Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01294826
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Swedish Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer Adenocarcinoma of the Colon Adenocarcinoma of the Rectum Drug: AUY922 Drug: Cetuximab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IB With Expansion of Patients at the MTD Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Study Start Date : February 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: AUY922 plus Cetuximab Drug: AUY922
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.

Drug: Cetuximab
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose limiting toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ]

Secondary Outcome Measures :
  1. Patient response rate to the AUY922. [ Time Frame: After 2 years ]
  2. Time to tumor progression following treatment with AUY922. [ Time Frame: After 2 years ]
  3. Overall survival of patients treated with AUY922. [ Time Frame: After 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed colorectal cancer
  • KRAS wild type metastatic colorectal cancer
  • Progression of disease on at least 2 prior therapy to have included 5FU, or oxaliplatin or bevacizumab or irinotecan
  • Prior treatment with cetuximab is allowed (full dose tolerated), provided that the patient never required a dose reduction due to toxicities
  • Must have at least one measurable lesion
  • Must be 18 years of age or older
  • ECOG performance status 0-1
  • Life expectancy must be greater than 12 weeks
  • For women of childbearing potential, a negative pregnancy blood test must be obtained less than 3 days prior to the first AUY922 infusion

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:

    • Radiotherapy, conventional chemotherapy: within 2 weeks
    • Palliative radiotherapy: within 2 weeks
    • Nitrosoureas, monoclonal antibodies, such as trastuzumab and mitomycin: within 6 weeks
    • Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday-Wednesday-Friday dosing, weekly etc.) of systemic anti-cancer treatment for which the recover period is not known, or investigational drugs (i.e. targeted agents) within a duration of ≤ 5 half lives of the agent and their active metabolites (if any)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294826


Locations
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United States, Washington
Swedish Medical Center Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Philip Gold, MD Swedish Medical Center Cancer Institute
More Information
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Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01294826    
Other Study ID Numbers: CAUY922AUS06T
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Swedish Medical Center:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
HSP90 Heat-Shock Proteins
EGFR protein, human
Additional relevant MeSH terms:
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Adenocarcinoma
Rectal Neoplasms
Colonic Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents