Trial · NCT02949700
Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma
NCT02949700, Phase 1, Phase 2, Completed, Baylor College of Medicine; results first posted 2022-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma. Trials, record NCT02949700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02949700
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma
- NCT number
- NCT02949700
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Metformin
- First posted
- 2016-10-31
- Last updated
- 2023-06-29
- Results first posted
- 2022-07-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I - Dose-Limiting Toxicity | treatment duration plus 30 days following treatment (an average of 13 weeks) | Dose limiting toxicities include diarrhea/gastrointestinal disturbance and hypoglycemia requiring dose reduction, and they will be measured for the time frame detailed above. Adverse Events (AE)s will be graded in accordance with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) http://ctep.cancer.gov/ reporting/ctc.html. If not described in the NCI-CTCAE, AEs will be graded according to their severity using the following criteria: grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (life threatening). |
| Primary | Phase II - Efficacy (Disease Response Rate) | Treatment duration plus 8-12 weeks following treatment completion (up to 21 weeks total) | Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) Committee \[Eur J Cancer. 2009 Jan; 45(2):228-47\]. Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST 1.1 criteria. For the purposes of this study, patients should be reevaluated for response following completion of treatment as per current institutional protocol for this disease site: 1) spiral contrast enhanced computed tomography (CECT) at 10 weeks following completion of treatment or 2) positron emission tomography (PET) at 12 weeks following completion of treatment. Per RECIST v1.1 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Disease response rate is defined as the percentage of patients with OR. |
| Secondary | Phase II - Progression Free Survival | Date of study registration to recurrence/progression/death or up to 2 years following treatment completion, whichever comes first. | Measurement of time from date of study registration to date of documented radiographic recurrence/progression or death. |
| Secondary | Phase II - Overall Survival | Date of study registration to death or up to 2 years following treatment completion, whichever comes first. | Measurement of time from date of study registration to date of death. |
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 | Phase I - Dose-Limiting Toxicity | treatment duration plus 30 days following treatment (an average of 13 weeks) | Participants were considered for Phase I toxicity (dose-limiting toxicity) evaluation if they were enrolled in the Phase I portion and took 70% or more of the study drug throughout the course of the trial. 9 out of 25 subjects (7 on DL1 (Phase I), 2 on DL2) met this criterion. | dose-limiting toxicities | NUMBER |
| PRIMARY | Phase II - Efficacy (Disease Response Rate) | Treatment duration plus 8-12 weeks following treatment completion (up to 21 weeks total) | Participants were considered for Phase II efficacy (disease response rate) evaluation if they were enrolled in the Phase II portion and took 70% or more of the study drug throughout the course of the trial. 7 out of 25 subjects (7 on DL1 (Phase II)) met this criterion. | percentage of participants with response | NUMBER |
| SECONDARY | Phase II - Progression Free Survival | Date of study registration to recurrence/progression/death or up to 2 years following treatment completion, whichever comes first. | Participants were considered for Phase II progression free survival evaluation if they were enrolled in the Phase II portion and took 70% or more of the study drug throughout the course of the trial. 7 out of 25 subjects (7 on DL1 (Phase II)) met this criterion. | months | MEAN |
| SECONDARY | Phase II - Overall Survival | Date of study registration to death or up to 2 years following treatment completion, whichever comes first. | Participants were considered for Phase II overall survival evaluation if they were enrolled in the Phase II portion and took 70% or more of the study drug throughout the course of the trial. 7 out of 25 subjects (7 on DL1 (Phase II)) met this criterion. | months | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I - Dose-Limiting Toxicity | Single Arm, Treatment: DL1 (Phase I) | 0 | dose-limiting toxicities | ||
| Phase I - Dose-Limiting Toxicity | Single Arm, Treatment: DL2 | 0 | dose-limiting toxicities | ||
| Phase II - Efficacy (Disease Response Rate) | Single Arm, Treatment: DL1 (Phase II) | 100.0 | 95% Confidence Interval 59.0 to 100.0 | percentage of participants with response | |
| Phase II - Progression Free Survival | Single Arm, Treatment: DL1 (Phase II) | 22.7 | 95% Confidence Interval 9.8 to 29.3 | months | |
| Phase II - Overall Survival | Single Arm, Treatment: DL1 (Phase II) | 22.7 | 95% Confidence Interval 9.8 to 29.3 | months |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I | STARTED | Single Arm, Treatment: DL1 (Phase I) | 9 | |
| Phase I | STARTED | Single Arm, Treatment: DL2 | 3 | |
| Phase I | STARTED | Single Arm, Treatment: DL-1 | 0 | |
| Phase I | STARTED | Single Arm, Treatment: DL1 (Phase II) | 0 | |
| Phase I | COMPLETED | Single Arm, Treatment: DL1 (Phase I) | 7 | |
| Phase I | COMPLETED | Single Arm, Treatment: DL2 | 2 | |
| Phase I | COMPLETED | Single Arm, Treatment: DL-1 | 0 | |
| Phase I | COMPLETED | Single Arm, Treatment: DL1 (Phase II) | 0 | |
| Phase I | NOT COMPLETED | Single Arm, Treatment: DL1 (Phase I) | 2 | |
| Phase I | NOT COMPLETED | Single Arm, Treatment: DL2 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events376
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 | Anemia | Blood and lymphatic system disorders | Single Arm, Treatment: DL1 (Phase I) | 7 | 9 | 13 |
| other | Anemia | Blood and lymphatic system disorders | Single Arm, Treatment: DL2 | 3 | 3 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Single Arm, Treatment: DL-1 | 1 | 1 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Single Arm, Treatment: DL1 (Phase II) | 7 | 12 | 18 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Single Arm, Treatment: DL1 (Phase I) | 1 | 9 | 3 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Single Arm, Treatment: DL2 | 0 | 3 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Single Arm, Treatment: DL-1 | 0 | 1 | 0 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Single Arm, Treatment: DL1 (Phase II) | 0 | 12 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Single Arm, Treatment: DL1 (Phase I) | 0 | 9 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Single Arm, Treatment: DL2 | 0 | 3 | 0 |
1 to 10 of 376Source ClinicalTrials.gov
See all 376 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm, Treatment: DL1 (Phase I) | 4 | 9 |
| Total, all-cause mortality | Single Arm, Treatment: DL2 | 2 | 3 |
| Total, all-cause mortality | Single Arm, Treatment: DL-1 | 0 | 1 |
| Total, all-cause mortality | Single Arm, Treatment: DL1 (Phase II) | 4 | 12 |
| Total, other adverse events | Single Arm, Treatment: DL1 (Phase I) | 8 | 9 |
| Total, other adverse events | Single Arm, Treatment: DL2 | 3 | 3 |
| Total, other adverse events | Single Arm, Treatment: DL-1 | 1 | 1 |
| Total, other adverse events | Single Arm, Treatment: DL1 (Phase II) | 12 | 12 |
| Total, serious adverse events | Single Arm, Treatment: DL1 (Phase I) | 1 | 9 |
| Total, serious adverse events | Single Arm, Treatment: DL2 | 2 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37562095 | DERIVED |
Source PubMed
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/NCT02949700
GET https://conductscience.org/api/trials/v1/NCT02949700/flow?page=2