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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01294826
First Posted: February 14, 2011
Last Update Posted: June 8, 2015
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.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Swedish Medical Center
February 8, 2011
February 14, 2011
June 8, 2015
February 2011
May 2015   (Final data collection date for primary outcome measure)
Incidence of dose limiting toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ]
Same as current
Complete list of historical versions of study NCT01294826 on ClinicalTrials.gov Archive Site
  • Patient response rate to the AUY922. [ Time Frame: After 2 years ]
  • Time to tumor progression following treatment with AUY922. [ Time Frame: After 2 years ]
  • Overall survival of patients treated with AUY922. [ Time Frame: After 2 years ]
Same as current
Not Provided
Not Provided
 
Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Phase IB With Expansion of Patients at the MTD Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • 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.
Experimental: AUY922 plus Cetuximab
Interventions:
  • Drug: AUY922
  • Drug: Cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01294826
CAUY922AUS06T
No
Not Provided
Not Provided
Swedish Medical Center
Swedish Medical Center
Novartis Pharmaceuticals
Principal Investigator: Philip Gold, MD Swedish Medical Center Cancer Institute
Swedish Medical Center
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP