Recruitment

Recruitment Status
Terminated
Estimated Enrollment
180

Inclusion Criterias

Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
Adequate glucose control, bone marrow, kidney, liver, and heart function.
Adequate performance status.
...
Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
Adequate glucose control, bone marrow, kidney, liver, and heart function.
Adequate performance status.
Advanced colorectal carcinoma.
Tumor tissue available at time of screening for molecular profiling.

Exclusion Criterias

History of interstitial lung disease.
Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
Prior irinotecan treatment.
...
History of interstitial lung disease.
Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
Prior irinotecan treatment.
Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
Deep vein thrombosis in the preceding 2 months.
Active brain metastases.
History of Gilbert's syndrome.
RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).

Summary

Conditions
Metastatic Colorectal Carcinoma
Type
Interventional
Phase
Phase 1 & Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
Adequate glucose control, bone marrow, kidney, liver, and heart function.
Adequate performance status.
...
Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
Adequate glucose control, bone marrow, kidney, liver, and heart function.
Adequate performance status.
Advanced colorectal carcinoma.
Tumor tissue available at time of screening for molecular profiling.

Exclusion Criterias

History of interstitial lung disease.
Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
Prior irinotecan treatment.
...
History of interstitial lung disease.
Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
Prior irinotecan treatment.
Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
Deep vein thrombosis in the preceding 2 months.
Active brain metastases.
History of Gilbert's syndrome.
RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).

Locations

Pasadena, California, 91105
Los Angeles, California, 90095
Seattle, Washington, 98101
Henderson, Nevada, 89052
Los Angeles, California, 90095-7349
...
Pasadena, California, 91105
Los Angeles, California, 90095
Seattle, Washington, 98101
Henderson, Nevada, 89052
Los Angeles, California, 90095-7349
Spokane, Washington, 99208
Fullerton, California, 92835
Kennewick, Washington, 99336
Los Angeles, California, 90095
Los Angeles, California, 90095-7349
Richland, Washington, 99352
Ottawa, Ontario, K1H 8 L6
Madrid, 28009
Spokane Valley, Washington, 99216
Las Vegas, Nevada, 89128
Spartanburg, South Carolina, 29303
Northridge, California, 91328
Henderson, Nevada, 89014
Seattle, Washington, 98101
Santa Monica, California, 90404
Los Angeles, California, 90095
Los Angeles, California, 90095
Cleveland, Ohio, 44109
Los Angeles, California, 90095
Los Angeles, California, 90095
Richland, Washington, 99352
Valencia, California, 91355
Los Angeles, California, 90095-7349
Spartanburg, South Carolina, 29303
Irvine, California, 92604
Toronto, Ontario, M5G 2M9
Las Vegas, Nevada, 89169
Santa Maria, California, 93454
Henderson, Nevada, 89074
Los Angeles, California, 90095
Las Vegas, Nevada, 89148
Westlake Village, California, 91361
Santa Monica, California, 90404
Barcelona, 08035

Tracking Information

NCT #
NCT01937715
Collaborators
Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer