Trial · NCT01720173

Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

NCT01720173, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2017-12-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer. Trials, record NCT01720173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01720173

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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 Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
NCT number: NCT01720173
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Gynecologic Oncology Group
Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Interventions: Dalantercept, Laboratory Biomarker Analysis
First posted: 2012-11-02
Last updated: 2021-10-20
Results first posted: 2017-12-08

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry	Every other cycle for first 6 months	Percentage of participants who survive progression-free for at least 6 months without non-protocol therapy after study entry. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Primary	Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up	Number of participants with a maximum grade of 3 or higher during the treatment period.
Primary	Objective Tumor Response	Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.	Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Secondary	Overall Survival	Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Secondary	Progression-free Survival	Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.	Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Other	Gene Expression Levels of ALK1 and Other Markers	Baseline	Associated with measures of clinical response to treatment, including PFS and OS.
Other	IHC Expression Levels of VEGF, FGF, TGFB, ALK1, CD105 and Other Markers	Baseline	Associated with measures of clinical response to treatment, including PFS and OS.
Other	Pre-treatment Plasma Concentration Levels of VEGF, BMP9, BMP10, and ALK1	Baseline	Associated with measures of clinical response to treatment, including PFS and OS.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry	Every other cycle for first 6 months	Eligible and treated participants	percentage of participants	NUMBER
PRIMARY	Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up	Eligible and treated patients	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Objective Tumor Response	Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.	Eligible and treated participants	percentage of participants	NUMBER
SECONDARY	Overall Survival	Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.	Eligible and treated participants.	months	MEDIAN
SECONDARY	Progression-free Survival	Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.	Eligible and treated participants	months	MEDIAN
OTHER_PRE_SPECIFIED	Gene Expression Levels of ALK1 and Other Markers	Baseline
OTHER_PRE_SPECIFIED	IHC Expression Levels of VEGF, FGF, TGFB, ALK1, CD105 and Other Markers	Baseline
OTHER_PRE_SPECIFIED	Pre-treatment Plasma Concentration Levels of VEGF, BMP9, BMP10, and ALK1	Baseline

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Category	Value	Spread	Units
Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry	Dalantercept		20	90% Confidence Interval 11 to 100	percentage of participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	Neutropenia	1		Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	Other Investigations	1		Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	Cardiac disorders	3		Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	Gastrointestinal disorders	2		Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	General disorders and administration site conditio	2		Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	Infections and infestations	3		Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	Metabolism and nutrition disorders	1		Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	Musculoskeletal and connective tissue disorders	1		Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Dalantercept	Renal and urinary disorders	1		Participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dalantercept	30
Overall Study	COMPLETED	Dalantercept	30
Overall Study	NOT COMPLETED	Dalantercept	0

Source ClinicalTrials.gov

Adverse events123

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	Lymph Node Pain	Blood and lymphatic system disorders	Dalantercept	1	30
other	Anemia	Blood and lymphatic system disorders	Dalantercept	21	30
other	Palpitations	Cardiac disorders	Dalantercept	3	30
other	Heart Failure	Cardiac disorders	Dalantercept	1	30
other	Sinus Tachycardia	Cardiac disorders	Dalantercept	2	30
other	Vertigo	Ear and labyrinth disorders	Dalantercept	1	30
other	Tinnitus	Ear and labyrinth disorders	Dalantercept	3	30
other	Ear Pain	Ear and labyrinth disorders	Dalantercept	2	30
other	Hyperparathyroidism	Endocrine disorders	Dalantercept	1	30
other	Eye Disorders - Other	Eye disorders	Dalantercept	1	30

1 to 10 of 123Source ClinicalTrials.gov

See all 123 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	30	30
Total, serious adverse events	Dalantercept	8	30

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/NCT01720173

GET https://conductscience.org/api/trials/v1/NCT01720173/events?page=2

API reference For AI assistants