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

Phase 1

Completed

• Conditions: Recurrent Rectal Cancer; Recurrent Colon Cancer; Stage IV Colon Cancer; Adenocarcinoma of the Colon; Stage IV Rectal Cancer; Adenocarcinoma of the Rectum
• Interventions: Drug: AUY922; Drug: Cetuximab

• Registration Number: NCT01294826
• Lead Sponsor: Swedish Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-14
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AUY922 plus Cetuximab	Cetuximab	-
AUY922 plus Cetuximab	AUY922	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose limiting toxicity (DLT)	1 cycle (1 cycle = 28 days)

Secondary Outcome Measures

Name	Time	Method
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.	After 2 years

Trial Locations

Locations (1)

Swedish Medical Center Cancer Institute; 🇺🇸 Seattle, Washington, United States