Trial · NCT01861301
Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma
NCT01861301, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2016-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma. Trials, record NCT01861301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01861301
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma
- NCT number
- NCT01861301
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Epithelioid Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatoid Mesothelioma, Stage II Pleural Mesothelioma, Stage III Pleural Mesothelioma, Stage IV Pleural Mesothelioma
- Interventions
- Laboratory Biomarker Analysis, Tivantinib
- First posted
- 2013-05-23
- Last updated
- 2016-10-24
- Results first posted
- 2016-10-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 1 year | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: 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. |
| Secondary | Incidence of Adverse Events, Graded Per NCI CTCAE Version 4 | Up to 2 years | Grade 3 or higher AE of any type, regardless of attribution. |
| Secondary | Overall Survival | Up to 2 years | Analyzed using the Kaplan-Meier method. |
| Secondary | Progression-free Survival | Up to 2 years | Time to disease progression or death from any cause. Analyzed using the Kaplan-Meier method. |
| Other | Change in Baseline Levels of Continuous or Ordinal Markers (e.g., Serum HGF/MET IHC) Between Responders and Non-responders | Baseline to 1 year | Fisher's exact test will be performed for binary variables (e.g., presence/absence of MET gene amplification). Paired t-tests or Wilcoxon signed-ranks test, whichever is appropriate, will be used to examine the changes with treatment in the laboratory correlates that are continuous and McNemar's test will be used for binary markers. |
| Other | Change in Serum HGF or MET IHC and Tumor Size Change (Percent Reduction in Sum of Longest Diameters) | Baseline to 1 year | Will be evaluated by Spearman's rank correlation coefficient. |
| Other | Association Between Baseline HGF, MET Gene Amplification, MET IHC and PFS | Baseline to 1 year | Will be evaluated using the Cox regression model. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 1 year | Note: Study terminated for futility due to insufficient number of objective responders in first stage. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Adverse Events, Graded Per NCI CTCAE Version 4 | Up to 2 years | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | Up to 2 years | Months | MEDIAN | |
| SECONDARY | Progression-free Survival | Up to 2 years | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Change in Baseline Levels of Continuous or Ordinal Markers (e.g., Serum HGF/MET IHC) Between Responders and Non-responders | Baseline to 1 year | |||
| OTHER_PRE_SPECIFIED | Change in Serum HGF or MET IHC and Tumor Size Change (Percent Reduction in Sum of Longest Diameters) | Baseline to 1 year | |||
| OTHER_PRE_SPECIFIED | Association Between Baseline HGF, MET Gene Amplification, MET IHC and PFS | Baseline to 1 year |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Treatment (Tivantinib) | 0 | 95% Confidence Interval 0 to 18.5 | percentage of participants | |
| Incidence of Adverse Events, Graded Per NCI CTCAE Version 4 | Treatment (Tivantinib) | 22.2 | 95% Confidence Interval 6.4 to 47.6 | percentage of participants | |
| Overall Survival | Treatment (Tivantinib) | 12.2 | 95% Confidence Interval 7.1 to 22.2 | Months | |
| Progression-free Survival | Treatment (Tivantinib) | 1.9 | 95% Confidence Interval 1.8 to 5.4 | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Tivantinib) | 18 | |
| Overall Study | COMPLETED | Treatment (Tivantinib) | 18 | |
| Overall Study | NOT COMPLETED | Treatment (Tivantinib) | 0 |
Source ClinicalTrials.gov
Adverse events60
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 | Abdominal distension | Gastrointestinal disorders | Treatment (Tivantinib) | 1 | 18 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Tivantinib) | 2 | 18 | |
| other | Alanine aminotransferase increased | Investigations | Treatment (Tivantinib) | 3 | 18 | |
| other | Alkaline phosphaase increased | Investigations | Treatment (Tivantinib) | 2 | 18 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Tivantinib) | 9 | 18 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Tivantinib) | 3 | 18 | |
| other | Anxiety | Psychiatric disorders | Treatment (Tivantinib) | 2 | 18 | |
| other | Aspartate aminotransferase increase | Investigations | Treatment (Tivantinib) | 5 | 18 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Treatment (Tivantinib) | 1 | 18 | |
| other | Blurred vision | Eye disorders | Treatment (Tivantinib) | 1 | 18 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Tivantinib) | ||
| Total, other adverse events | Treatment (Tivantinib) | 17 | 18 |
| Total, serious adverse events | Treatment (Tivantinib) | 3 | 18 |
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 |
|---|---|---|---|---|---|
| P30CA014599 | Cancer Center Support Grant | ODUNSI, KUNLE | UNIVERSITY OF CHICAGO | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source 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/NCT01861301
GET https://conductscience.org/api/trials/v1/NCT01861301/events?page=2