Trial · NCT01642082

Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer

NCT01642082, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2016-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer. Trials, record NCT01642082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01642082

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Trial

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

Title: Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer
NCT number: NCT01642082
Status: Completed
Phases: Phase 2
Enrollment: 28 participants, actual
Lead sponsor: Gynecologic Oncology Group
Conditions: Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma, Endometrial Mucinous Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Squamous Cell Carcinoma, Endometrial Transitional Cell Carcinoma, Endometrial Undifferentiated Carcinoma, Recurrent Uterine Corpus Carcinoma
Interventions: Dalantercept, Laboratory Biomarker Analysis
First posted: 2012-07-17
Last updated: 2018-03-13
Results first posted: 2016-02-05

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Response	Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed.	Response was defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and based on imaging done every other cycle. Responses can be either partial or complete. Per RECIST v1.1 target and non-target lesions are assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target and non-target lesions and all lymph nodes must be \< 10 mm in short axis; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
Primary	Treatment and Progression-free Survival at 6 Months	CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease	Treatment and Progression-free Survival is defined as the duration alive from study entry until progression is documented, death or non-protocol treatment is initiated; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions. Non-protocol treatment initiation prior to disease progression and prior to 6 months from study entry was counted as an event for treatment and progression-free survival at 6 months. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for treatment and progression-free survival at 6 months.
Secondary	Progression-free Survival at 6 Months	: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.	Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for progression-free survival at 6 months.
Secondary	Duration of Progression-free Survival	CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.	Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.
Secondary	Duration of Survival	Patients are followed every three months for the first two years and then every six months for the next three years.	Duration of survival is defined as the duration alive from study entry until death or last contact.
Secondary	Adverse Events (Primary Serious and All Other AEs)	Every cycle of study treatment and after treatment for a maximum of 5 years from study entry	The frequencies of the maximum grade of any acute adverse event, regardless of attribution are reported during treatment and up to 30 days after stopping the study treatment are reported.

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	Response	Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed.	All eligible and treated patients	percentage of participants	NUMBER
PRIMARY	Treatment and Progression-free Survival at 6 Months	CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease	All eligible and treated patients	percentage of participants	NUMBER
SECONDARY	Progression-free Survival at 6 Months	: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.	All eligible and treated patients	percentage of participants	NUMBER
SECONDARY	Duration of Progression-free Survival	CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.	All eligible and treated patients.	months	MEDIAN
SECONDARY	Duration of Survival	Patients are followed every three months for the first two years and then every six months for the next three years.	All eligible and treated patients	months	MEDIAN
SECONDARY	Adverse Events (Primary Serious and All Other AEs)	Every cycle of study treatment and after treatment for a maximum of 5 years from study entry	Eligible and treated patients	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group227

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

Outcome	Group	Category	Value	Spread	Units
Response	Dalantercept		0	90% Confidence Interval 0 to 10.1	percentage of participants
Treatment and Progression-free Survival at 6 Months	Dalantercept		10.7	90% Confidence Interval 3 to 25.4	percentage of participants
Progression-free Survival at 6 Months	Dalantercept		17.9	90% Confidence Interval 7.3 to 33.9	percentage of participants
Duration of Progression-free Survival	Treatment (Dalantercept)		2.1	90% Confidence Interval 1.4 to 3.2	months
Duration of Survival	Dalantercept		14.5	90% Confidence Interval 7.0 to 17.5	months
Adverse Events (Primary Serious and All Other AEs)	Grade 0	Anemia	13		Participants
Adverse Events (Primary Serious and All Other AEs)	Grade 1 (CTCAE v4.0)	Anemia	5		Participants
Adverse Events (Primary Serious and All Other AEs)	Grade 2 (CTCAE v4.0)	Anemia	8		Participants
Adverse Events (Primary Serious and All Other AEs)	Grade 3 (CTCAE v 4.0)	Anemia	1		Participants
Adverse Events (Primary Serious and All Other AEs)	Grade 4 (CTCAE v 4.0)	Anemia	1		Participants

1 to 10 of 227Source ClinicalTrials.gov

See all 227 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dalantercept	28
Overall Study	COMPLETED	Dalantercept	28
Overall Study	NOT COMPLETED	Dalantercept	0

Source ClinicalTrials.gov

Adverse events106

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	Anemia	Blood and lymphatic system disorders	Dalantercept	15	28
other	Ventricular Arrhythmia	Cardiac disorders	Dalantercept	1	28
other	Tinnitus	Ear and labyrinth disorders	Dalantercept	1	28
other	Hearing Impaired	Ear and labyrinth disorders	Dalantercept	1	28
other	Ear Pain	Ear and labyrinth disorders	Dalantercept	2	28
other	Flashing Lights	Eye disorders	Dalantercept	1	28
other	Eye Pain	Eye disorders	Dalantercept	2	28
other	Blurred Vision	Eye disorders	Dalantercept	3	28
other	Floaters	Eye disorders	Dalantercept	1	28
other	Dysphagia	Gastrointestinal disorders	Dalantercept	1	28

1 to 10 of 106Source ClinicalTrials.gov

See all 106 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dalantercept
Total, other adverse events	Dalantercept	28	28
Total, serious adverse events	Dalantercept	11	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

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/NCT01642082

GET https://conductscience.org/api/trials/v1/NCT01642082/results?page=2

API reference For AI assistants