Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT01479465 |
Recruitment Status :
Terminated
First Posted : November 24, 2011
Results First Posted : April 17, 2019
Last Update Posted : April 17, 2019
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Colorectal Cancer |
Interventions |
Biological: Simtuzumab Drug: Placebo to match SIM Drug: Leucovorin Drug: Irinotecan Drug: Fluorouracil |
Enrollment | 266 |
Participant Flow
Recruitment Details | Participants were enrolled at study sites in the United States, Russia, and Europe. The first participant was screened on 15 December 2011. The last study visit occurred on 27 February 2015. |
Pre-assignment Details | 358 participants were screened. |
Arm/Group Title | FOLFIRI + SIM 700 mg (Part A) | FOLFIRI + Placebo (Part B) | FOLFIRI + SIM 200 mg (Part B) | FOLFIRI + SIM 700 mg (Part B) |
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Participants received simtuzumab (SIM) 700 mg via intravenous infusion followed by leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI; l-leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours and irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes, followed by fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours) on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months. | Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months. | Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months. | Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months. |
Period Title: Overall Study | ||||
Started | 11 | 84 | 86 | 85 |
Completed | 0 | 0 | 0 | 0 |
Not Completed | 11 | 84 | 86 | 85 |
Reason Not Completed | ||||
Disease Progression | 9 | 61 | 65 | 70 |
Study Discontinued by Sponsor | 0 | 7 | 5 | 3 |
Adverse Event | 0 | 3 | 6 | 4 |
Investigator Discretion | 1 | 4 | 2 | 4 |
Subject Request | 1 | 3 | 4 | 2 |
Subject Withdrew Consent | 0 | 5 | 2 | 1 |
Protocol Violation | 0 | 1 | 1 | 0 |
Death | 0 | 0 | 0 | 1 |
Lost to Follow-up | 0 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | FOLFIRI + SIM 700 mg (Part A) | FOLFIRI + Placebo (Part B) | FOLFIRI + SIM 200 mg (Part B) | FOLFIRI + SIM 700 mg (Part B) | Total | |
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Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 10 months. | Participants received placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 27 months. | Participants received SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 21 months. | Participants received SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycles for approximately 19 months. | Total of all reporting groups | |
Overall Number of Baseline Participants | 11 | 84 | 86 | 85 | 266 | |
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All randomized participants were analyzed.
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Age, Customized
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 80 participants | 85 participants | 84 participants | 260 participants | |
Between 18 and 65 years |
7 63.6%
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57 71.3%
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49 57.6%
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56 66.7%
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169 65.0%
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≥ 65 years |
4 36.4%
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23 28.7%
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36 42.4%
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28 33.3%
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91 35.0%
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[1]
Measure Description: Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
[2]
Measure Analysis Population Description: Participants in Full Analysis Set were analyzed.
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 11 participants | 80 participants | 85 participants | 84 participants | 260 participants | |
Female |
6 54.5%
|
41 51.2%
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32 37.6%
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48 57.1%
|
127 48.8%
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Male |
5 45.5%
|
39 48.8%
|
53 62.4%
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36 42.9%
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133 51.2%
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[1]
Measure Analysis Population Description: Participants in Full Analysis Set were analyzed.
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 11 participants | 80 participants | 85 participants | 84 participants | 260 participants |
White |
8 72.7%
|
67 83.8%
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74 87.1%
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71 84.5%
|
220 84.6%
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Black or African American |
2 18.2%
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8 10.0%
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5 5.9%
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7 8.3%
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22 8.5%
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Asian |
1 9.1%
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1 1.3%
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5 5.9%
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1 1.2%
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8 3.1%
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Native Hawaiian or Pacific Islander |
0 0.0%
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1 1.3%
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0 0.0%
|
1 1.2%
|
2 0.8%
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Not Permitted |
0 0.0%
|
3 3.8%
|
1 1.2%
|
3 3.6%
|
7 2.7%
|
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Missing |
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 1.2%
|
1 0.4%
|
|
[1]
Measure Analysis Population Description: Participants in Full Analysis Set were analyzed.
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Ethnicity | Number Analyzed | 11 participants | 80 participants | 85 participants | 84 participants | 260 participants |
Non-Hispanic/Latino |
8 72.7%
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70 87.5%
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75 88.2%
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73 86.9%
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226 86.9%
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Hispanic/Latino |
3 27.3%
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5 6.3%
|
7 8.2%
|
8 9.5%
|
23 8.8%
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Not Permitted |
0 0.0%
|
5 6.3%
|
3 3.5%
|
3 3.6%
|
11 4.2%
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[1]
Measure Analysis Population Description: Participants in Full Analysis Set were analyzed.
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 11 participants | 84 participants | 86 participants | 85 participants | 266 participants |
11 100.0%
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45 53.6%
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47 54.7%
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45 52.9%
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148 55.6%
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Poland | Number Analyzed | 11 participants | 84 participants | 86 participants | 85 participants | 266 participants |
0 0.0%
|
5 6.0%
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7 8.1%
|
5 5.9%
|
17 6.4%
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Italy | Number Analyzed | 11 participants | 84 participants | 86 participants | 85 participants | 266 participants |
0 0.0%
|
7 8.3%
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7 8.1%
|
4 4.7%
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18 6.8%
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France | Number Analyzed | 11 participants | 84 participants | 86 participants | 85 participants | 266 participants |
0 0.0%
|
4 4.8%
|
1 1.2%
|
3 3.5%
|
8 3.0%
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Germany | Number Analyzed | 11 participants | 84 participants | 86 participants | 85 participants | 266 participants |
0 0.0%
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5 6.0%
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4 4.7%
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7 8.2%
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16 6.0%
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Spain | Number Analyzed | 11 participants | 84 participants | 86 participants | 85 participants | 266 participants |
0 0.0%
|
9 10.7%
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13 15.1%
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8 9.4%
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30 11.3%
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Russia | Number Analyzed | 11 participants | 84 participants | 86 participants | 85 participants | 266 participants |
0 0.0%
|
9 10.7%
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7 8.1%
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13 15.3%
|
29 10.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
- The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
- The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: | Gilead Clinical Study Information Center |
Organization: | Gilead Sciences |
Phone: | 1-833-445-3230 (GILEAD-0) |
EMail: | GileadClinicalTrials@gilead.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01479465 |
Other Study ID Numbers: |
GS-US-295-0203 2011-003754-61 ( EudraCT Number ) |
First Submitted: | November 9, 2011 |
First Posted: | November 24, 2011 |
Results First Submitted: | March 26, 2019 |
Results First Posted: | April 17, 2019 |
Last Update Posted: | April 17, 2019 |