Trial · NCT01605318
Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer
NCT01605318, Phase 1, Phase 2, Terminated, Gilead Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer. Trials, record NCT01605318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01605318
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer
- NCT number
- NCT01605318
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Interventions
- Labetuzumab Govitecan (LG)
- First posted
- 2012-05-24
- Last updated
- 2024-01-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events and Serious Adverse Events (SAEs) | From first dose date up to approximately 2 years after the last dose or until disease progression | |
| Primary | Percentage of Participants With Laboratory Abnormalities | From first dose date up to approximately 2 years after the last dose or until disease progression | |
| Secondary | Duration of Response | From first documentation of PR or CR to the earlier of the first documentation of PD or death from any cause (Up to approximately 2 years after the last dose or until disease progression) | Duration of response (DOR) is defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression (PD) or death from any cause. |
| Secondary | Progression-free Survival | From first dose date up to 12 weeks post treatment (Up to approximately 2 years after the last dose or until disease progression) | Progression free survival (PFS) is defined as the interval from the start of study drug treatment to the earlier of the first documentation of disease progression or death from any cause. |
| Secondary | Time to Progression | From first dose of study treatment up to PD (Up to approximately 2 years after the last dose or until disease progression) | Time to progression is defined as the interval from the first dose of treatment to the first documentation of disease progression (PD). |
| Secondary | Overall Survival | From first dose date up to approximately 2 years | Overall survival is defined as the time from start of study drug treatment to death from any cause. |
| Secondary | Time-to-treatment Failure | From first dose date up to 8 treatment cycles (each cycle = 21 days) (Up to approximately 24 weeks) | Time to treatment failure (TTF) is defined as the interval from the start of treatment to the earlier of the first documentation of disease progression or death due to any cause, the permanent cessation of LG therapy due to all reasons except progressive disease, participant died or lost to follow up. |
| Secondary | Change from Baseline in Carcinoembryonic Antigen (CEA) Serum Levels | From first dose date up to approximately 2 years after the last dose or until disease progression |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01605318
GET https://conductscience.org/api/trials/v1/NCT01605318/registered