Trial · NCT02795156
Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations
NCT02795156, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2023-09-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations. Trials, record NCT02795156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02795156
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations
- NCT number
- NCT02795156
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Non-small Cell Lung Carcinoma, Urothelial Carcinoma, Gastrointestinal Carcinoma, Non-colon, Upper Aerodigestive Tract Carcinoma
- Interventions
- Afatinib, Regorafenib, Cabozantinib
- First posted
- 2016-06-09
- Last updated
- 2023-12-05
- Results first posted
- 2023-09-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | every 8 weeks until tumor progression or treatment discontinuation, up to 45 months. | ORR is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR), i.e., two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Clinical Benefit Rate in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months | Clinical Benefit Rate (CBR) is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR) or stable disease (SD) ≥ 6 months according to RECIST v1.1. Confirmed response is defined as two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease= Neither sufficient shrinkage to qualify for PR nor sufficient increase of 20% in the sum of diameters or presence of a new lesion to qualify for progressive disease (PD), taking as reference the smallest (nadir) sum of diameters since the treatment started. |
| Secondary | Time to Treatment Failure (TTF) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months | Time to treatment failure is measured from the first day of treatment until the patient is removed from study for toxicity, disease progression per RECIST v1.1, patient choice, or death. Progressive disease (PD) per RECIST v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over the sum. |
| Secondary | Progression-Free Survival in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months | Progression Free Survival (PFS) is defined as the time from the first day of study drug administration (Day 1) to disease progression as defined by the RECIST v1.1, or death on study. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment. Progressive disease (PD) per RECIST v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over the sum. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | every 8 weeks until tumor progression or treatment discontinuation, up to 45 months. | All enrolled patients are included. | percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months | All enrolled participants are included. | percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Failure (TTF) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months | All enrolled participants were included. | months | MEDIAN |
| SECONDARY | Progression-Free Survival in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months | All enrolled participants were included. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 1 | 10.3 | 95% Confidence Interval 2.87 to 24.22 | percentage of participants | |
| Overall Response Rate (ORR) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 2 | 0 | 95% Confidence Interval NA to NA | percentage of participants | |
| Overall Response Rate (ORR) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 3 | 7.1 | 95% Confidence Interval 1.5 to 19.48 | percentage of participants | |
| Overall Response Rate (ORR) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 4 | 0 | 95% Confidence Interval NA to NA | percentage of participants | |
| Clinical Benefit Rate in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 1 | 15.4 | 95% Confidence Interval 5.86 to 30.5 | percentage of participants | |
| Clinical Benefit Rate in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 2 | 0 | 95% Confidence Interval NA to NA | percentage of participants | |
| Clinical Benefit Rate in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 3 | 21.4 | 95% Confidence Interval 10.3 to 36.8 | percentage of participants | |
| Clinical Benefit Rate in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 4 | 11.1 | 95% Confidence Interval .28 to 48.2 | percentage of participants | |
| Time to Treatment Failure (TTF) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 1 | 2.1 | 95% Confidence Interval 1.6 to 2.8 | months | |
| Time to Treatment Failure (TTF) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations | Arm 2 | 1.8 | 95% Confidence Interval 1.1 to 1.9 | months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 39 | |
| Overall Study | STARTED | Arm 2 | 10 | |
| Overall Study | STARTED | Arm 3 | 42 | |
| Overall Study | STARTED | Arm 4 | 9 | |
| Overall Study | COMPLETED | Arm 1 | 0 | |
| Overall Study | COMPLETED | Arm 2 | 0 | |
| Overall Study | COMPLETED | Arm 3 | 0 | |
| Overall Study | COMPLETED | Arm 4 | 0 | |
| Overall Study | NOT COMPLETED | Arm 1 | 39 | |
| Overall Study | NOT COMPLETED | Arm 2 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,052
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 | Diarrhoea | Gastrointestinal disorders | Arm 1 | 17 | 39 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 2 | 10 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 3 | 22 | 42 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 4 | 3 | 9 | |
| other | Nausea | Gastrointestinal disorders | Arm 1 | 20 | 39 | |
| other | Nausea | Gastrointestinal disorders | Arm 2 | 7 | 10 | |
| other | Nausea | Gastrointestinal disorders | Arm 3 | 18 | 42 | |
| other | Nausea | Gastrointestinal disorders | Arm 4 | 1 | 9 | |
| other | Vomiting | Gastrointestinal disorders | Arm 1 | 11 | 39 | |
| other | Vomiting | Gastrointestinal disorders | Arm 2 | 5 | 10 |
1 to 10 of 1,052Source ClinicalTrials.gov
See all 1,052 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | 14 | 39 |
| Total, all-cause mortality | Arm 2 | 1 | 10 |
| Total, all-cause mortality | Arm 3 | 13 | 42 |
| Total, all-cause mortality | Arm 4 | 3 | 9 |
| Total, other adverse events | Arm 1 | 39 | 39 |
| Total, other adverse events | Arm 2 | 10 | 10 |
| Total, other adverse events | Arm 3 | 41 | 42 |
| Total, other adverse events | Arm 4 | 8 | 9 |
| Total, serious adverse events | Arm 1 | 16 | 39 |
| Total, serious adverse events | Arm 2 | 6 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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/NCT02795156
GET https://conductscience.org/api/trials/v1/NCT02795156/events?page=2