Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT02906059
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to determine whether combination therapy of irinotecan with AZD1775 is safe and effective in treating mutated metastatic colorectal cancer patients.

Key Dates

Start date
Sep 30, 2016
Status verified
Oct 2020
Primary completion
Mar 12, 2020
Completion
Mar 12, 2020

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AZD1775 & Irinotecan
    Group AZD1775 (study drug); Irinotecan (chemotherapy) 1\) 125 mg two times a day (BID) for 3 days every 2 weeks; 180mg/m2 every 2 weeks 2A) 150 mg BID for 3 days every 2 weeks; 180mg/m2 every 2 weeks 2B) 125 mg BID for 5 days every 2 weeks; 180mg/m2 every 2 weeks 3\) 150 mg BID for 5 days every 2 weeks ; 180mg/m2 every 2 weeks

Primary Outcome Measure

Number of participants dose limiting toxicities with treatment-related adverse events as assessed by common terminology criteria for adverse events (CTCAE), version 4. [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-

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Laura and Isaac Perlmutter Cancer Center· New York, NY

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