Trial · NCT01643278
Dasatinib and Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumors or Other Sarcomas That Cannot Be Removed by Surgery or Are Metastatic
NCT01643278, Phase 1, Completed, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib and Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumors or Other Sarcomas That Cannot Be Removed by Surgery or Are Metastatic. Trials, record NCT01643278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01643278
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib and Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumors or Other Sarcomas That Cannot Be Removed by Surgery or Are Metastatic
- NCT number
- NCT01643278
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 29 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Gastrointestinal Stromal Tumor, Stage III Soft Tissue Sarcoma, Stage IV Soft Tissue Sarcoma
- Interventions
- Dasatinib, Ipilimumab, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2012-07-18
- Last updated
- 2017-01-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose defined as the highest dose studied for which the observed incidence of dose-limiting toxicity is less than 33% according to the National Cancer Institute Common Toxicity Criteria | Up to week 12 | Frequencies of toxicities will be tabulated. |
| Secondary | OS as measured by RECIST 1.1, Choi and immune-related response criteria | Up to 3 years | Will be estimated using Kaplan-Meier methodology. |
| Secondary | PFS as measured by RECIST 1.1, Choi and immune-related response criteria | From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years | Will be estimated using Kaplan-Meier methodology. |
| Secondary | PFS at 6 months as measured by RECIST 1.1, Choi and immune-related response criteria | 6 months | Will be estimated using Kaplan-Meier methodology. |
| Secondary | RR as measured by RECIST 1.1, Choi and immune-related response criteria | Up to 3 years | Immune related response rate (complete response + partial response) and Choi criteria will be calculated along with a 95% confidence interval. |
| Other | Change in humoral and cellular immune response | Baseline to up to 4 weeks after treatment | Relationships between clinical response, lymphocyte phenotype, cytokines, and effect of dasatinib and ipilimumab on humoral and cellular immune responses will be evaluated. Summary statistics for peripheral blood biomarkers of immunoregulatory activity (T-cell subpopulation counts, cytokines, and corresponding changes \[or % changes\]) will be tabulated by study day/dose. Time courses of biomarker measures will be investigated graphically; further analysis may be performed to characterize relationships. Associations between changes and dasatinib exposure will be explored graphically. |
| Other | Change in tumor immunological markers in patients treated at the expansion cohort (as of May 2015 patients on expansion cohort will not undergo protocol biopsies) | Baseline to up to week 6 | Summary statistics for measures and changes from baseline of tumor-based markers including T-cell (cluster of differentiation \[CD\] 4, CD8, CD45, forkhead box P3), apoptosis markers, and indoleamine 2,3-dioxygenase 1/2 will be tabulated. Associations between biomarkers and efficacy measures will be analyzed in all response-evaluable subjects. |
| Other | Downstream molecular effects of therapy on tumor viability as measured by changes in KIT expression and secondary mutations in resistant tumor specimens | Baseline to up to 4 weeks after treatment | Changes will be correlated with tumor response by Fisher's exact test. |
| Other | Genotype (v-Kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog [KIT] and platelet-derived growth factor receptor-alpha [PDGFR-a]) mutation status | Baseline | Associations of mutation status with response rate and PFS6months will be assessed using Fisher's exact test. Associations of mutation status with PFS and overall survival will be assessed using the log rank test. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| U01CA069856 | Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis | SPRIGGS, DAVID R | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
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/NCT01643278
GET https://conductscience.org/api/trials/v1/NCT01643278/registered