Trial · NCT02917629
ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment
NCT02917629, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2023-03-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment. Trials, record NCT02917629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02917629
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment
- NCT number
- NCT02917629
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Oral Cavity Neoplasm, Oropharyngeal Neoplasm, Stage 0 Oral Cavity Squamous Cell Carcinoma American Joint Committee on Cancer (AJCC) v6 and v7, Stage 0 Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage I Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage I Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage II Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage II Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Interventions
- Laboratory Biomarker Analysis, Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet, Pharmacological Study, Placebo
- First posted
- 2016-09-28
- Last updated
- 2023-03-08
- Results first posted
- 2023-03-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Proliferation Index (Ki-67) Expression, Assessed in Tumor Tissue by Immunohistochemistry | Baseline to days 11-22 | Baseline, post-exposure, absolute change in Ki-67, and difference in absolute change between the ACTOplus met XR and placebo subjects will all be summarized with descriptive statistics. Ki-67 is a semi-quantitative immune-histochemistry analysis in which a computer generates an analysis based on the staining within tumor and normal cells leading to a score which is an indirect measure of cellular proliferation. Will compare the difference in absolute change in Ki-67 between the ACTOplus met XR and placebo arms using a two sided two-sample Student's t-test or Wilcoxon rank-sum test, as appropriate, at a significance level of 0.05. |
| Secondary | Change in Ki-67 Expression in Visually Normal Appearing Tissue, Assessed by Immunohistochemistry | Baseline to days 11-22 | Will be summarized for baseline, post-exposure, and absolute change by treatment arm using the appropriate descriptive statistics, and will be evaluated with Student's t-test or Wilcoxon rank-sum test. |
| Secondary | Change in Cleaved Caspase 3 Expression in Visually Normal Appearing Tissue and Tumor Tissue Samples, Assessed by Immunohistochemistry | Baseline to days 11-22 | Cleaved Caspase 3 is a semi-quantitative immune-histochemistry analysis in which a computer generates an analysis based on the staining within tumor and normal cells leading to a score which is a direct measure of cellular apoptosis. Will be summarized for baseline, post-exposure, and absolute change by treatment arm using the appropriate descriptive statistics, and will be evaluated with Student's t-test or Wilcoxon rank-sum test. |
| Secondary | Change in Cyclin D1, p21 and Biguanide or Phosphorylated AKT, Phosphorylated AMPK, Phosphorylated S6 (Metformin), and PPAR Gamma Expression, Assessed by Immunohistochemistry | Baseline to days 11-22 | Will be summarized for baseline, post-exposure, and absolute change by treatment arm using the appropriate descriptive statistics, and will be evaluated with Student's t-test or Wilcoxon rank-sum test. |
| Secondary | Change in Regulatory T Cell, T4, T8, Tumor-associated Macrophage-CD68 Positive, PD1, PD-L1 Expression, Assessed in Tumor Tissue by Immunohistochemistry | Baseline to days 11-22 | Will be summarized for baseline, post-exposure, and absolute change by treatment arm using the appropriate descriptive statistics, and will be evaluated with Student's t-test or Wilcoxon rank-sum test. |
| Secondary | Genes With Significant Changes From Baseline to Days 11-22 in Tumor Tissue in Treated Participants: Change in Whole Transcriptome Gene Analysis on Total Ribonucleic Acid Samples | Baseline to days 11-22 | Will be summarized for baseline, post-exposure, and absolute change by treatment arm using the appropriate descriptive statistics, and will be evaluated with Student's t-test or Wilcoxon rank-sum test. |
| Secondary | Genes With Significant Changes From Baseline to Days 11-22 for Normal Tissue: Change in Whole Transcriptome Gene Analysis on Total Ribonucleic Acid Samples | Baseline to days 11-22 | Will be summarized for baseline, post-exposure, and absolute change by treatment arm using the appropriate descriptive statistics, and will be evaluated with Student's t-test or Wilcoxon rank-sum test. |
| Secondary | Genes With Significant Changes From Baseline to Days 11-22 for Tumor-Normal Tissue: Change in Whole Transcriptome Gene Analysis on Total Ribonucleic Acid Samples | Baseline to days 11-22 | The plan was to summarize for baseline, post-exposure, and absolute change by treatment arm using the appropriate descriptive statistics, and will be evaluated with Student's t-test or Wilcoxon rank-sum test. |
| Secondary | Human Papillomavirus Status Assessed in Tumor Tissue by p16 by Immunohistochemistry | Baseline | Human papillomavirus status will be assessed in tumor tissue by p16 by immunohistochemistry. |
| Other | Change in Tumor Fluorodeoxyglucose Uptake/Metabolism Assess by Treatment Positron Emission Tomography/Computed Tomography | Baseline to days 11-22 | Tumor fluorodeoxyglucose uptake/metabolism assess by treatment positron emission tomography/computed tomography. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in Proliferation Index (Ki-67) Expression, Assessed in Tumor Tissue by Immunohistochemistry | Baseline to days 11-22 | 1 sample in the treatment group was not analyzed because site misplaced the sample. | proliferation index expression | MEDIAN |
| SECONDARY | Change in Ki-67 Expression in Visually Normal Appearing Tissue, Assessed by Immunohistochemistry | Baseline to days 11-22 | 1 sample in the treatment group was not analyzed because site misplaced the sample. | proliferation index expression | MEDIAN |
| SECONDARY | Change in Cleaved Caspase 3 Expression in Visually Normal Appearing Tissue and Tumor Tissue Samples, Assessed by Immunohistochemistry | Baseline to days 11-22 | 1 sample in the treatment group was not analyzed because site misplaced the sample. | percent positive cells | MEAN |
| SECONDARY | Change in Cyclin D1, p21 and Biguanide or Phosphorylated AKT, Phosphorylated AMPK, Phosphorylated S6 (Metformin), and PPAR Gamma Expression, Assessed by Immunohistochemistry | Baseline to days 11-22 | 1 sample in the treatment group was not analyzed because site misplaced the sample. | percent positive cells | MEDIAN |
| SECONDARY | Change in Regulatory T Cell, T4, T8, Tumor-associated Macrophage-CD68 Positive, PD1, PD-L1 Expression, Assessed in Tumor Tissue by Immunohistochemistry | Baseline to days 11-22 | 1 sample in the treatment group was not analyzed because site misplaced the sample. | percent positive cells | MEDIAN |
| SECONDARY | Genes With Significant Changes From Baseline to Days 11-22 in Tumor Tissue in Treated Participants: Change in Whole Transcriptome Gene Analysis on Total Ribonucleic Acid Samples | Baseline to days 11-22 | Pre- and post-treatment RNA-seq data was available in four ACTOplus treated participants and one placebo treated participant. Because of this, a comparison between the treatment arms was not deemed to be possible or useful. What was attempted was an analysis of change from baseline values for the ACTOplus met® XR arm. | raw counts of RNA sequencing reads | MEAN |
| SECONDARY | Genes With Significant Changes From Baseline to Days 11-22 for Normal Tissue: Change in Whole Transcriptome Gene Analysis on Total Ribonucleic Acid Samples | Baseline to days 11-22 | Pre- and post-treatment RNA-seq data was available in four ACTOplus treated participants and one placebo treated participant. Because of this, a comparison between the treatment arms was not deemed to be possible or useful. What was attempted was an analysis of change from baseline values for the ACTOplus met® XR arm. | raw counts of RNA sequencing reads | MEAN |
| SECONDARY | Genes With Significant Changes From Baseline to Days 11-22 for Tumor-Normal Tissue: Change in Whole Transcriptome Gene Analysis on Total Ribonucleic Acid Samples | Baseline to days 11-22 | Pre- and post-treatment RNA-seq data was available in four ACTOplus treated participants and one placebo treated participant. Because of this, a comparison between the treatment arms was not deemed to be possible or useful. What was attempted was an analysis of change from baseline values for the ACTOplus met® XR arm. | raw counts of RNA sequencing reads | MEAN |
| SECONDARY | Human Papillomavirus Status Assessed in Tumor Tissue by p16 by Immunohistochemistry | Baseline | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Change in Tumor Fluorodeoxyglucose Uptake/Metabolism Assess by Treatment Positron Emission Tomography/Computed Tomography | Baseline to days 11-22 | No one consented to this aspect of the study, no data is available. |
Source ClinicalTrials.gov
Results by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Proliferation Index (Ki-67) Expression, Assessed in Tumor Tissue by Immunohistochemistry | Group I (ACTOplus Met XR) | baseline | 20.40 | Inter-Quartile Range 19.84 to 25.10 | proliferation index expression |
| Absolute Change in Proliferation Index (Ki-67) Expression, Assessed in Tumor Tissue by Immunohistochemistry | Group II (Placebo) | baseline | 13.69 | Inter-Quartile Range 12.91 to 14.46 | proliferation index expression |
| Absolute Change in Proliferation Index (Ki-67) Expression, Assessed in Tumor Tissue by Immunohistochemistry | Group I (ACTOplus Met XR) | Day 11-22 | 17.57 | Inter-Quartile Range 17.17 to 17.64 | proliferation index expression |
| Absolute Change in Proliferation Index (Ki-67) Expression, Assessed in Tumor Tissue by Immunohistochemistry | Group II (Placebo) | Day 11-22 | 36.96 | Inter-Quartile Range 36.96 to 36.96 | proliferation index expression |
| Absolute Change in Proliferation Index (Ki-67) Expression, Assessed in Tumor Tissue by Immunohistochemistry | Group I (ACTOplus Met XR) | absolute change from baseline | -2.68 | Inter-Quartile Range -7.46 to -2.60 | proliferation index expression |
| Absolute Change in Proliferation Index (Ki-67) Expression, Assessed in Tumor Tissue by Immunohistochemistry | Group II (Placebo) | absolute change from baseline | 24.82 | Inter-Quartile Range 24.82 to 24.82 | proliferation index expression |
| Change in Ki-67 Expression in Visually Normal Appearing Tissue, Assessed by Immunohistochemistry | Group I (ACTOplus Met XR) | baseline | 17.58 | Inter-Quartile Range 15.18 to 17.68 | proliferation index expression |
| Change in Ki-67 Expression in Visually Normal Appearing Tissue, Assessed by Immunohistochemistry | Group II (Placebo) | baseline | 14.52 | Inter-Quartile Range 11.66 to 17.38 | proliferation index expression |
| Change in Ki-67 Expression in Visually Normal Appearing Tissue, Assessed by Immunohistochemistry | Group I (ACTOplus Met XR) | Day 11-22 | 11.81 | Inter-Quartile Range 10.02 to 14.23 | proliferation index expression |
| Change in Ki-67 Expression in Visually Normal Appearing Tissue, Assessed by Immunohistochemistry | Group II (Placebo) | Day 11-22 | 26.05 | Inter-Quartile Range 26.05 to 26.05 | proliferation index expression |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group I (ACTOplus Met XR) | 4 | |
| Overall Study | STARTED | Group II (Placebo) | 2 | |
| Overall Study | Considered Study Compliant | Group I (ACTOplus Met XR) | 4 | |
| Overall Study | Considered Study Compliant | Group II (Placebo) | 1 | |
| Overall Study | Experienced Study Drug Interruption | Group I (ACTOplus Met XR) | 2 | |
| Overall Study | Experienced Study Drug Interruption | Group II (Placebo) | 1 | |
| Overall Study | COMPLETED | Group I (ACTOplus Met XR) | 4 | |
| Overall Study | COMPLETED | Group II (Placebo) | 1 | |
| Overall Study | NOT COMPLETED | Group I (ACTOplus Met XR) | 0 | |
| Overall Study | NOT COMPLETED | Group II (Placebo) | 1 |
Source ClinicalTrials.gov
Adverse events16
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 | Hypertension | Vascular disorders | Group I (ACTOplus Met XR) | 1 | 4 | 1 |
| other | Hypertension | Vascular disorders | Group II (Placebo) | 1 | 2 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Group I (ACTOplus Met XR) | 1 | 4 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Group II (Placebo) | 0 | 2 | 0 |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Group I (ACTOplus Met XR) | 1 | 4 | 1 |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Group II (Placebo) | 0 | 2 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Group I (ACTOplus Met XR) | 1 | 4 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Group II (Placebo) | 0 | 2 | 0 |
| other | Nausea | Gastrointestinal disorders | Group I (ACTOplus Met XR) | 1 | 4 | 2 |
| other | Nausea | Gastrointestinal disorders | Group II (Placebo) | 0 | 2 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group I (ACTOplus Met XR) | 0 | 4 |
| Total, all-cause mortality | Group II (Placebo) | 0 | 2 |
| Total, other adverse events | Group I (ACTOplus Met XR) | 4 | 4 |
| Total, other adverse events | Group II (Placebo) | 2 | 2 |
| Total, serious adverse events | Group I (ACTOplus Met XR) | 0 | 4 |
| Total, serious adverse events | Group II (Placebo) | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| P30CA014520 | UW Comprehensive Cancer Center Support | CAPITINI, CHRISTIAN | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group I (ACTOplus Met XR) vs Group II (Placebo): deaths from any cause | Trial comparisons |
| Group I (ACTOplus Met XR) vs Group II (Placebo): 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/NCT02917629
GET https://conductscience.org/api/trials/v1/NCT02917629/results?page=2