Trial · NCT00768144

Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

NCT00768144, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2014-12-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma. Trials, record NCT00768144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00768144

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
NCT number: NCT00768144
Status: Completed
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Interventions: Sunitinib
First posted: 2008-10-07
Last updated: 2018-08-24
Results first posted: 2014-12-02

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate	Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.	Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Secondary	16-Week Progression-Free Survival	Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.	16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods. Patients alive and progression-free at last follow-up are censored. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.
Secondary	Progression-Free Survival	Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.	Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate	Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.	The analysis dataset is comprised of all treated patients.	proportion of participants	NUMBER
SECONDARY	16-Week Progression-Free Survival	Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.	The analysis dataset is comprised of all treated patients.	probability	NUMBER
SECONDARY	Progression-Free Survival	Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.	The analysis dataset is comprised of all treated patients.	weeks	MEDIAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Response Rate	Sunitinib	.083	90% Confidence Interval .024 to .210	proportion of participants
16-Week Progression-Free Survival	Sunitinib	.36	95% Confidence Interval .20 to .52	probability
Progression-Free Survival	Sunitinib	9.9	95% Confidence Interval 7.1 to 16.4	weeks

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sunitinib	36
Overall Study	COMPLETED	Sunitinib	0
Overall Study	NOT COMPLETED	Sunitinib	36

Source ClinicalTrials.gov

Adverse events56

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
other	Hypertension	Vascular disorders	Sunitinib	36	36
other	Fatigue	General disorders	Sunitinib	36	36
other	Vomiting	Gastrointestinal disorders	Sunitinib	36	36
other	Anemia	Blood and lymphatic system disorders	Sunitinib	8	36
other	White blood cell increased	Investigations	Sunitinib	11	36
other	Platelet count decreased	Investigations	Sunitinib	16	36
other	Weight loss	Investigations	Sunitinib	2	36
other	Anorexia	Metabolism and nutrition disorders	Sunitinib	4	36
other	Diarrhea	Gastrointestinal disorders	Sunitinib	23	36
other	Nausea	Gastrointestinal disorders	Sunitinib	36	36

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sunitinib
Total, other adverse events	Sunitinib	36	36
Total, serious adverse events	Sunitinib	7	36

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00768144

GET https://conductscience.org/api/trials/v1/NCT00768144/events?page=2

API reference For AI assistants