Trial · NCT01592383
Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma
NCT01592383, Phase 2, Completed, University of Chicago; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma. Trials, record NCT01592383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01592383
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib Hydrochloride in Treating Patients With Malignant Peritoneal Mesothelioma
- NCT number
- NCT01592383
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Malignant Peritoneal Mesothelioma
- Interventions
- erlotinib hydrochloride
- First posted
- 2012-05-07
- Last updated
- 2018-10-16
- Results first posted
- 2018-10-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | 1 year | Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
| Secondary | PFS | 1 year | Progression free survival (PFS) defined as time from study enrollment until disease progression or death. |
| Secondary | OS | 1 year | Overall survival measured as the time from study enrollment until death. |
| Secondary | Toxicity | 30 days from the last dose of study drug | Toxicity is calculated in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0 |
| Secondary | Disease Control Rate - SD + PR + CR | 1 year | Disease Control Rate - SD + PR + CR is calculated as the percentage of patients with either complete response (CR: disappearance of all target lesions), or with partial response (PR: at least 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease of an increase of at least 20% in the sum of the longest diameter of the target lesions taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions). |
| Secondary | EGFR Mutations Percentage | Baseline | EGFR Mutations Percentage is calculated as the percentage of patients who have activating EGFR mutations among all screened patients. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | 1 year | The study was terminated early after the enrollment of two participants and the data were not collected. | ||
| SECONDARY | PFS | 1 year | The study was terminated early after the enrollment of two participants and the data were not collected. | ||
| SECONDARY | OS | 1 year | The study was terminated early after the enrollment of two participants and the data were not collected. | ||
| SECONDARY | Toxicity | 30 days from the last dose of study drug | The study was terminated early after the enrollment of two participants and the data were not collected. | ||
| SECONDARY | Disease Control Rate - SD + PR + CR | 1 year | The study was terminated early after the enrollment of two participants and the data were not collected. | ||
| SECONDARY | EGFR Mutations Percentage | Baseline | The study was terminated early after the enrollment of two participants and the data were not collected. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Enzyme Inhibitor Therapy) | 2 | |
| Overall Study | COMPLETED | Treatment (Enzyme Inhibitor Therapy) | 1 | |
| Overall Study | NOT COMPLETED | Treatment (Enzyme Inhibitor Therapy) | 1 |
Source ClinicalTrials.gov
Adverse events3
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 | Rash maculo-papular | Skin and subcutaneous tissue disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 2 | 2 |
| other | Fatigue | General disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 2 | 2 |
| other | Constipation | General disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 2 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Enzyme Inhibitor Therapy) | 0 | 2 |
| Total, other adverse events | Treatment (Enzyme Inhibitor Therapy) | 1 | 2 |
| Total, serious adverse events | Treatment (Enzyme Inhibitor Therapy) | 0 | 2 |
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 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/NCT01592383
GET https://conductscience.org/api/trials/v1/NCT01592383/registered