Trial · NCT01035658
Pazopanib/Doxil in Adv Relapsed Plat Sensitive or Resistant Ovarian, Fallopian or Primary Peritoneal Adenocarcinoma
NCT01035658, Phase 1, Phase 2, Terminated, SCRI Development Innovations, LLC; results first posted 2015-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib/Doxil in Adv Relapsed Plat Sensitive or Resistant Ovarian, Fallopian or Primary Peritoneal Adenocarcinoma. Trials, record NCT01035658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01035658
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib/Doxil in Adv Relapsed Plat Sensitive or Resistant Ovarian, Fallopian or Primary Peritoneal Adenocarcinoma
- NCT number
- NCT01035658
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- Interventions
- Pazopanib, Doxil
- First posted
- 2009-12-21
- Last updated
- 2021-10-28
- Results first posted
- 2015-05-21
- Limitations and caveats
Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin | 18 months | The MTD of the drug combination will be determined as the highest dose at which ≤1 of 6 subjects experiences a Grade 3 or Grade 4 DLT according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. |
| Primary | Phase I - Dose Limiting Toxicities | 18 months | As requested, this outcome measure reports the number of patients experiencing dose limiting toxicities (DLTs) in the Phase I portion of the study |
| Primary | Phase II: Progression Free Survival | 18 months | Defined as from date of randomization until objective tumor progression or death. Response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) and CA-125 response in patients using the Rustin Criteria. |
| Secondary | Phase II - Overall Survival of Patients With Relapsed/Refractory Ovarian Cancer Following Treatment With Pazopanib and Liposomal Doxorubicin | 18 months | |
| Secondary | Response Rate in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma | 18 months | The response rate in the subsets of patients with platinum-sensitive and platinum-refractory ovarian carcinoma is evaluated as a measure of efficacy of pazopanib/liposomal doxorubicin. Response rate ( Percentage of patients whose disease decreased (Partial response - PR) and/or disappears (Complete response - CR) after treatment) was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) and CA-125 response in patients using the Rustin Criteria. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is \>= 30% decrease in the sum of longest diameter(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. |
| Secondary | Number of Participants Experiencing Adverse Events With the Combination of Pazopanib and Liposomal Doxorubicin Doses | 18 months | An adverse event (AE) is the development of an undesirable medical condition, or the deterioration of a pre-existing medical condition (other than the condition that is being treated by the trial) following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The number of participants experiencing such adverse events that are possibly/probably/definitely related to the study drugs are reported here. |
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 | Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin | 18 months | mg | NUMBER | |
| PRIMARY | Phase I - Dose Limiting Toxicities | 18 months | participants | NUMBER | |
| PRIMARY | Phase II: Progression Free Survival | 18 months | Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted. | ||
| SECONDARY | Phase II - Overall Survival of Patients With Relapsed/Refractory Ovarian Cancer Following Treatment With Pazopanib and Liposomal Doxorubicin | 18 months | Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted. | ||
| SECONDARY | Response Rate in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma | 18 months | Two patients stopped treatment prior to first reevaluation and hence were not included in the analysis. one patient's Recurrence status is unknown and thus was not evaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Adverse Events With the Combination of Pazopanib and Liposomal Doxorubicin Doses | 18 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin | Phase 1 | Pazopanib | 400 | mg | |
| Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin | Phase 1 | Liposomal doxorubicin | 30 | mg | |
| Phase I - Dose Limiting Toxicities | Dose Level 1 | 3 | participants | ||
| Phase I - Dose Limiting Toxicities | Dose Level -1 | 1 | participants | ||
| Phase I - Dose Limiting Toxicities | Dose Level 1 Sequential | 0 | participants | ||
| Phase I - Dose Limiting Toxicities | Dose Level 2 Sequential | 0 | participants | ||
| Response Rate in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma | Platinum Refractory Disease | 3 | Participants | ||
| Response Rate in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma | Platinum Sensitive Disease | 5 | Participants | ||
| Number of Participants Experiencing Adverse Events With the Combination of Pazopanib and Liposomal Doxorubicin Doses | Dose Level 1 | 5 | Participants | ||
| Number of Participants Experiencing Adverse Events With the Combination of Pazopanib and Liposomal Doxorubicin Doses | Dose Level -1 | 7 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 | 5 | |
| Overall Study | STARTED | Dose Level -1 | 8 | |
| Overall Study | STARTED | Dose Level 1 Sequential | 3 | |
| Overall Study | STARTED | Dose Level 2 Sequential | 6 | |
| Overall Study | COMPLETED | Dose Level 1 | 5 | |
| Overall Study | COMPLETED | Dose Level -1 | 8 | |
| Overall Study | COMPLETED | Dose Level 1 Sequential | 3 | |
| Overall Study | COMPLETED | Dose Level 2 Sequential | 6 | |
| Overall Study | NOT COMPLETED | Dose Level 1 | 0 | |
| Overall Study | NOT COMPLETED | Dose Level -1 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events120
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 | White blood cell decreased | Investigations | Dose Level 1 | 2 | 5 | |
| other | White blood cell decreased | Investigations | Dose Level -1 | 5 | 8 | |
| other | White blood cell decreased | Investigations | Dose Level 1 Sequential | 1 | 3 | |
| other | White blood cell decreased | Investigations | Dose Level 2 Sequential | 2 | 6 | |
| other | Neutrophil count decreased | Investigations | Dose Level 1 | 1 | 5 | |
| other | Neutrophil count decreased | Investigations | Dose Level -1 | 3 | 8 | |
| other | Neutrophil count decreased | Investigations | Dose Level 1 Sequential | 1 | 3 | |
| other | Neutrophil count decreased | Investigations | Dose Level 2 Sequential | 3 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 1 | 3 | 5 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level -1 | 2 | 8 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 4 | 5 |
| Total, all-cause mortality | Dose Level -1 | 7 | 8 |
| Total, all-cause mortality | Dose Level 1 Sequential | 3 | 3 |
| Total, all-cause mortality | Dose Level 2 Sequential | 1 | 6 |
| Total, other adverse events | Dose Level 1 | 5 | 5 |
| Total, other adverse events | Dose Level -1 | 8 | 8 |
| Total, other adverse events | Dose Level 1 Sequential | 3 | 3 |
| Total, other adverse events | Dose Level 2 Sequential | 6 | 6 |
| Total, serious adverse events | Dose Level 1 | 3 | 5 |
| Total, serious adverse events | Dose Level -1 | 1 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Platinum Refractory Disease vs Platinum Sensitive Disease: Response Rate in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma |
Source 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/NCT01035658
GET https://conductscience.org/api/trials/v1/NCT01035658/events?page=2