Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
Public ClinicalTrials.gov record NCT01479465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.
Study identification
- NCT ID
- NCT01479465
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 266 participants
Conditions and interventions
Conditions
Interventions
- Simtuzumab Biological
- Placebo to match SIM Drug
- Leucovorin Drug
- Irinotecan Drug
- Fluorouracil Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2011 (Actual)
- Primary completion
- Oct 2014 (Actual)
- Completion
- Feb 2015 (Actual)
- Last update posted
- Apr 17, 2019
2011 – 2015
United States locations
- U.S. sites
- 56
- U.S. states
- 26
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35801 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | — | — |
| Central Hematology Oncology Medical Group, Inc. | Alhambra | California | — | — |
| Comprehensive Blood and Cancer Center | Bakersfield | California | — | — |
| Providence Saint Joseph Medical Center-Disney Family Cancer Center | Burbank | California | — | — |
| Wilshire Oncology Medical Group, Inc. | Corona | California | — | — |
| Saint Jude Heritage Healthcare | Fullerton | California | — | — |
| University of California San Diego Medical Center | La Jolla | California | — | — |
| Pacific Shores Medical Group | Long Beach | California | — | — |
| Comprehensive Hematology Oncology Centers, Inc. | Los Angeles | California | — | — |
| TORI Network (Translational Oncology Research Intl) | Los Angeles | California | — | — |
| UCLA Community Oncology Practice | Los Angeles | California | — | — |
| Stanford University Medical Center | Palo Alto | California | — | — |
| Wilshire Oncology Medical Group, Inc. | Pomona | California | — | — |
| Cancer Care Associates Medical Group | Redondo Beach | California | — | — |
| Pacific Shores Medical Group | Redondo Beach | California | — | — |
| Sharp Health Care | San Diego | California | — | — |
| San Jose Medical Group | San Jose | California | — | — |
| Central Coast Medical Oncology Corp | Santa Maria | California | — | — |
| Yale University Smilow Cancer Hospital | New Haven | Connecticut | 06520 | — |
| Georgetown University | Washington D.C. | District of Columbia | — | — |
| Florida Cancer Specialists | Gainesville | Florida | — | — |
| MD Anderson Cancer Center | Orlando | Florida | — | — |
| Florida Cancer Specialists | St. Petersburg | Florida | — | — |
| Peachtree Hematology Oncology Consultants, PC | Atlanta | Georgia | — | — |
| Suburban Hematology Oncology Associates, PC | Lawrenceville | Georgia | — | — |
| Northwestern University | Chicago | Illinois | — | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | — | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | — | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | — | — |
| Hematology and Oncology Associates at BridgePoint | Tupelo | Mississippi | — | — |
| Saint Joseph Oncology, Inc. | Saint Joseph | Missouri | — | — |
| Montana Cancer Institute | Missoula | Montana | 59802 | — |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | — | — |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | — | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | — | — |
| New York University Clinical Cancer Center | New York | New York | 10016 | — |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | — | — |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | — | — |
| Oncology Hematology Care, Inc. | Wilmington | Ohio | — | — |
| Kaiser Permanente Northwest Region Oncology Hematology | Portland | Oregon | — | — |
| South Carolina Oncology Associates | Columbia | South Carolina | — | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | — | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | — | — |
| Center for Cancer and Blood Disorders, PC | Fort Worth | Texas | — | — |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | — | — |
| Scott & White Memorial | Temple | Texas | 76508 | — |
| The Center for Cancer and Blood Disorders | Weatherford | Texas | — | — |
| Utah Cancer Specialists | Salt Lake City | Utah | — | — |
| Intermountain Healthcare | St. George | Utah | — | — |
| Virginal Cancer Specialists, PC | Fairfax | Virginia | 22033 | — |
| Virginia Cancer Institute | Midlothian | Virginia | — | — |
| Virginia Cancer Institute | Richmond | Virginia | — | — |
| Seattle Cancer Care Alliance | Seattle | Washington | — | — |
| University of Wisconsin | Madison | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01479465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 17, 2019 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01479465 live on ClinicalTrials.gov.