Trial · NCT01610206
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
NCT01610206, Phase 2, Completed, Linda R Duska; results first posted 2021-02-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer. Trials, record NCT01610206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01610206
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
- NCT number
- NCT01610206
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- Linda R Duska
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Interventions
- Gemcitabine, pazopanib
- First posted
- 2012-06-01
- Last updated
- 2021-02-25
- Results first posted
- 2021-02-25
- Limitations and caveats
Our study is limited by lack of placebo control, independent pathology and radiologic review, and correlative science. We did not collect data regarding quality of life, and the study was performed in an unselected patient population.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | 3 years | Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of recurrence/progression or death from any cause, whichever occurs first. |
| Secondary | Number of Participants With Adverse Events | 30 days after last dose | Adverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | 3 years | months | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | 30 days after last dose | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Progression-free Survival | Gemcitabine | 2.9 | 95% Confidence Interval 2.1 to 4.1 | months | |
| Progression-free Survival | Gemcitabine + Pazopanib | 5.3 | 95% Confidence Interval 4.2 to 5.8 | months | |
| Number of Participants With Adverse Events | Gemcitabine | 73 | Participants | ||
| Number of Participants With Adverse Events | Gemcitabine + Pazopanib | 75 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine | 73 | |
| Overall Study | STARTED | Gemcitabine + Pazopanib | 75 | |
| Overall Study | COMPLETED | Gemcitabine | 63 | |
| Overall Study | COMPLETED | Gemcitabine + Pazopanib | 45 | |
| Overall Study | NOT COMPLETED | Gemcitabine | 10 | |
| Overall Study | NOT COMPLETED | Gemcitabine + Pazopanib | 30 |
Source ClinicalTrials.gov
Adverse events254
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 | Gemcitabine | 26 | 73 | |
| other | anemia | Blood and lymphatic system disorders | Gemcitabine + Pazopanib | 11 | 75 | |
| other | febrile neutropenia | Blood and lymphatic system disorders | Gemcitabine | 0 | 73 | |
| other | febrile neutropenia | Blood and lymphatic system disorders | Gemcitabine + Pazopanib | 1 | 75 | |
| other | heart failure | Cardiac disorders | Gemcitabine | 0 | 73 | |
| other | heart failure | Cardiac disorders | Gemcitabine + Pazopanib | 1 | 75 | |
| other | tinnitus | Ear and labyrinth disorders | Gemcitabine | 3 | 73 | |
| other | tinnitus | Ear and labyrinth disorders | Gemcitabine + Pazopanib | 1 | 75 | |
| other | vertigo | Ear and labyrinth disorders | Gemcitabine | 0 | 73 | |
| other | vertigo | Ear and labyrinth disorders | Gemcitabine + Pazopanib | 2 | 75 |
1 to 10 of 254Source ClinicalTrials.gov
See all 254 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine | 54 | 73 |
| Total, all-cause mortality | Gemcitabine + Pazopanib | 63 | 75 |
| Total, other adverse events | Gemcitabine | 73 | 73 |
| Total, other adverse events | Gemcitabine + Pazopanib | 75 | 75 |
| Total, serious adverse events | Gemcitabine | 20 | 73 |
| Total, serious adverse events | Gemcitabine + Pazopanib | 63 | 75 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gemcitabine vs Gemcitabine + Pazopanib: Number of Participants With Adverse Events | Trial comparisons |
| Gemcitabine vs Gemcitabine + Pazopanib: deaths from any cause | Trial comparisons |
| Gemcitabine vs Gemcitabine + Pazopanib: 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/NCT01610206
GET https://conductscience.org/api/trials/v1/NCT01610206/events?page=2