Trial · NCT01874665
A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor
NCT01874665, Phase 2, Completed, Ariad Pharmaceuticals; results first posted 2016-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor. Trials, record NCT01874665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01874665
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor
- NCT number
- NCT01874665
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Ariad Pharmaceuticals
- Conditions
- GIST
- Interventions
- Ponatinib
- First posted
- 2013-06-11
- Last updated
- 2018-05-18
- Results first posted
- 2016-05-17
- Limitations and caveats
- Study is ongoing. Uncontrolled Study. Small participant population. Non-randomized.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) in Cohort A | 16 weeks after first dose | To assess clinical benefit rate in participants with KIT exon 11-mutant GIST.It is defined as the composite of complete response(CR),partial response(PR),and stable disease(SD) lasting \>=16 weeks per modified Response Evaluation Criteria In Solid Tumors(RECIST) 1.1 as a measure of disease control.CR is complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.All nodes, both target and non-target, must decrease to normal (short axis \<10millimeter \[mm\]).No new lesions.PR is \>=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD is not qualifying for CR,PR,Progressive Disease(PD).PD is \>=20% increase from the smallest prior sum of the longest diameter(SLD)and with \>=5mm absolute increase, or appearance of a new lesion. |
| Secondary | Clinical Benefit Rate (CBR) in Cohort B | 16 weeks after first dose | To assess clinical benefit rate in participants with GIST that lacks KIT exon 11 mutations (Cohort B) and in the total participant population. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 millimeter \[mm\]). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, PD. |
| Secondary | Progression-free Survival (PFS) | From date of enrollment until the end of the study or disease progression or death due to any cause, whichever came first, assessed up to 3 years | PFS is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever may come first. To assess PFS in each cohort and in the total participant population. |
| Secondary | Percentage of Participants With Objective Response Rate (ORR) | From date of enrollment until discontinuation or the end of the study, whichever came first, assessed up to 3 years | ORR is defined as the composite of CR and PR per Response Evaluation Criteria in RECIST 1.1, assessed for each cohort and in the total participant population. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. |
| Secondary | Overall Survival (OS) | From first dose of drug until the end of the study or death, whichever came first, assessed up to 3 years | OS is defined as the time interval between the first dose of study drug to death due to any cause. Overall survival was analyzed using the Kaplan-Meier method. |
| Secondary | Number of Participants With Physical Examination | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Sign Measurements | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Laboratory Parameters | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants With TEAEs Related to Electrocardiogram (ECG) Findings | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants With TEAEs Related to Echocardiography Parameter | From date of enrollment until the End-of-Treatment, assessed up to 3 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Benefit Rate (CBR) in Cohort A | 16 weeks after first dose | The ITT population included all participants who received any dose of ponatinib in the study. The ITT population where data at specified time points was available. | percentage (%) of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) in Cohort B | 16 weeks after first dose | The ITT population included all participants who received any dose of ponatinib in the study. | percentage (%) of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | From date of enrollment until the end of the study or disease progression or death due to any cause, whichever came first, assessed up to 3 years | The ITT population included all participants who received any dose of ponatinib in the study. | days | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response Rate (ORR) | From date of enrollment until discontinuation or the end of the study, whichever came first, assessed up to 3 years | The ITT population included all participants who received any dose of ponatinib in the study. The ITT population where data at specified time points was available. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From first dose of drug until the end of the study or death, whichever came first, assessed up to 3 years | The ITT population included all participants who received any dose of ponatinib in the study. | days | MEDIAN |
| SECONDARY | Number of Participants With Physical Examination | From date of enrollment until the End-of-Treatment, assessed up to 3 years | The ITT population included all participants who received any dose of ponatinib in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Sign Measurements | From date of enrollment until the End-of-Treatment, assessed up to 3 years | The ITT population included all participants who received any dose of ponatinib in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Laboratory Parameters | From date of enrollment until the End-of-Treatment, assessed up to 3 years | The ITT population included all participants who received any dose of ponatinib in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs Related to Electrocardiogram (ECG) Findings | From date of enrollment until the End-of-Treatment, assessed up to 3 years | The ITT population included all participants who received any dose of ponatinib in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs Related to Echocardiography Parameter | From date of enrollment until the End-of-Treatment, assessed up to 3 years | The ITT population included all participants who received any dose of ponatinib in the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Benefit Rate (CBR) in Cohort A | Cohort A | 35.7 | 95% Confidence Interval 18.6 to 55.9 | percentage (%) of participants | |
| Clinical Benefit Rate (CBR) in Cohort B | Cohort B | 20.0 | 95% Confidence Interval 4.3 to 48.1 | percentage (%) of participants | |
| Progression-free Survival (PFS) | Cohort A | 112.0 | 95% Confidence Interval 57.0 to 252.0 | days | |
| Progression-free Survival (PFS) | Cohort B | 57.0 | 95% Confidence Interval 55.0 to 502.0 | days | |
| Percentage of Participants With Objective Response Rate (ORR) | Cohort A | 7.1 | 95% Confidence Interval 0.9 to 23.5 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) | Cohort B | 0.0 | 95% Confidence Interval 0.0 to 21.8 | percentage of participants | |
| Overall Survival (OS) | Cohort A | 411.0 | 95% Confidence Interval 234.0 to 836.0 | days | |
| Overall Survival (OS) | Cohort B | 399.0 | 95% Confidence Interval 90.0 to NA | days | |
| Number of Participants With Physical Examination | Cohort A | 6 | Participants | ||
| Number of Participants With Physical Examination | Cohort B | 1 | Participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 30 | |
| Overall Study | STARTED | Cohort B | 15 | |
| Overall Study | COMPLETED | Cohort A | 0 | |
| Overall Study | COMPLETED | Cohort B | 0 | |
| Overall Study | NOT COMPLETED | Cohort A | 30 | |
| Overall Study | NOT COMPLETED | Cohort B | 15 |
Source ClinicalTrials.gov
Adverse events442
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort A | 1 | 30 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort B | 5 | 15 | |
| other | ATRIAL FIBRILLATION | Cardiac disorders | Cohort A | 1 | 30 | |
| other | ATRIAL FIBRILLATION | Cardiac disorders | Cohort B | 2 | 15 | |
| other | HYPOTHYROIDISM | Endocrine disorders | Cohort A | 3 | 30 | |
| other | HYPOTHYROIDISM | Endocrine disorders | Cohort B | 1 | 15 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort A | 14 | 30 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Cohort B | 6 | 15 | |
| other | ASCITES | Gastrointestinal disorders | Cohort A | 3 | 30 | |
| other | ASCITES | Gastrointestinal disorders | Cohort B | 1 | 15 |
1 to 10 of 442Source ClinicalTrials.gov
See all 442 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 4 | 30 |
| Total, all-cause mortality | Cohort B | 2 | 15 |
| Total, other adverse events | Cohort A | 30 | 30 |
| Total, other adverse events | Cohort B | 15 | 15 |
| Total, serious adverse events | Cohort A | 20 | 30 |
| Total, serious adverse events | Cohort B | 6 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A vs Cohort B: Number of Participants With Physical Examination | Trial comparisons |
| Cohort A vs Cohort B: deaths from any cause | Trial comparisons |
| Cohort A vs Cohort B: serious adverse events | Trial comparisons |
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/NCT01874665
GET https://conductscience.org/api/trials/v1/NCT01874665/results?page=2