Trial · NCT01914510
A Study of ENMD-2076 in Ovarian Clear Cell Cancers
NCT01914510, Phase 2, Completed, University Health Network, Toronto; results first posted 2019-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of ENMD-2076 in Ovarian Clear Cell Cancers. Trials, record NCT01914510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01914510
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ENMD-2076 in Ovarian Clear Cell Cancers
- NCT number
- NCT01914510
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- University Health Network, Toronto
- Conditions
- Ovarian Clear Cell Carcinoma
- Interventions
- ENMD-2076
- First posted
- 2013-08-02
- Last updated
- 2019-12-13
- Results first posted
- 2019-12-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Six Month Progression Free Survival Rate | Response will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. Progression free survival is the time from the first day of treatment to the first observation of disease progression or Death/last F/U. | Progression Free Survival (PFS) is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause or last follow up. PFS will be censored for patients who are alive and free of progression at time of last follow-up. |
| Primary | Complete or Partial Response Rate | 2 years | Percentage of patients with complete or partial response as per RECIST 1.1 criteria. |
| Secondary | Time to Disease Progression | 2 years | Length of time until disease progression in patients treated with ENMD-2076 |
| Secondary | Levels of Certain Proteins and Gene Expression Compared to Patient Outcome Following Treatment | 2 years | Association of somatic mutations in PIK3CA, ARID1A and PTEN mutation status, and ARID1A and PTEN expression assessed in archival samples and tumour biopsies with tumour response and patient outcome following treatment with ENMD 2076. |
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 | Six Month Progression Free Survival Rate | Response will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. Progression free survival is the time from the first day of treatment to the first observation of disease progression or Death/last F/U. | Of the 40 participants enrolled, 38 were deemed eligible for evaluation. Two patients did not complete one cycle of therapy and were considered not evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Complete or Partial Response Rate | 2 years | Of the 40 participants enrolled onto trial, 38 were deemed eligible for evaluation. 2 patients did not complete a cycle of therapy and were considered ineligible for evaluation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Disease Progression | 2 years | Data not collected. | ||
| SECONDARY | Levels of Certain Proteins and Gene Expression Compared to Patient Outcome Following Treatment | 2 years | Data not collected |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Six Month Progression Free Survival Rate | ENMD-2076 | 8 | Participants | ||
| Complete or Partial Response Rate | ENMD-2076 | 3 | Participants |
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 | ENMD-2076 | 40 | |
| Overall Study | COMPLETED | ENMD-2076 | 38 | |
| Overall Study | NOT COMPLETED | ENMD-2076 | 2 |
Source ClinicalTrials.gov
Adverse events32
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 | Fatigue | General disorders | ENMD-2076 | 28 | 40 | 28 |
| other | Nausea | Gastrointestinal disorders | ENMD-2076 | 27 | 40 | 27 |
| other | Constipation | Gastrointestinal disorders | ENMD-2076 | 23 | 40 | 23 |
| other | Diarrhea | Gastrointestinal disorders | ENMD-2076 | 20 | 40 | 20 |
| other | Hypomagnesemia | Metabolism and nutrition disorders | ENMD-2076 | 19 | 40 | 19 |
| other | Headache | General disorders | ENMD-2076 | 18 | 40 | 18 |
| other | Vomiting | Gastrointestinal disorders | ENMD-2076 | 16 | 40 | 16 |
| other | Weight Loss | General disorders | ENMD-2076 | 15 | 40 | 15 |
| other | Hypoalbuminemia | Blood and lymphatic system disorders | ENMD-2076 | 15 | 40 | 15 |
| other | Proteinuria | Renal and urinary disorders | ENMD-2076 | 14 | 40 | 14 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ENMD-2076 | 0 | 40 |
| Total, other adverse events | ENMD-2076 | 40 | 40 |
| Total, serious adverse events | ENMD-2076 | 10 | 40 |
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/NCT01914510
GET https://conductscience.org/api/trials/v1/NCT01914510/events?page=2