Registered outcomes14

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

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability.	Assessed from time of first dose to approximately 30 days after last dose. Participants were allowed to remain on treatment until documented disease progression. The time frame for Part 1 of the study was up to 21.6 months	Outcome measure is intended for Part 1 of the study in order to determine recommended dose level for Part 2.
Primary	Part 2: Progression Free Survival (PFS).	Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months	PFS was defined as the time from randomization to the date of first documentation of disease progression based on RECIST (version 1.1) or to death due to any cause, whichever occurred first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. RECIST 1.1 defines disease progression as an increase of at least a 20% in the sum of 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 is also considered progression)
Secondary	Part 1: Progression Free Survival (PFS).	The time frame for Part 1 of the study was up to 21.6 months	PFS was defined as the time from randomization to the date of first documentation of disease progression based on RECIST (version 1.1) or to death due to any cause, whichever occurred first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Secondary	Part 1: Overall Survival (OS). [The Time Frame for Part 1 of the Study Was up to 21.6 Months]	Up to 21.6 months	Percentage of Part 1 subjects alive at the end of Part 1 of the study. \[The time frame for Part 1 of the study was up to 21.6 months\]
Secondary	Part 1: Objective Response Rate (ORR)	Up to 21.6 months from randomization in Part 1 of the study	Objective response rate (ORR) is defined as the number and percentage of patients who have a partial response (PR) or complete response (CR) to therapy. A CR is defined 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. A PR is defined as a decrease of at least a 30% in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As no subjects in Part 1 experienced a CR, the ORR in Part 1 is defined by the PR
Secondary	Part 1: Disease Control Rate (DCR)	From randomization up to 21.6 months in Part 1 of the study	The number and percentage of patients whose disease shrinks or remains stable. DCR is the sum of the complete, partial and stable disease rates.
Secondary	Part 1: Duration of Response (DoR)	From randomization up to 21.6 months in Part 1 of the study.	Response duration is measured from the time measurement criteria are first met for objective response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study.
Secondary	Part 2: Progression Free Survival (PFS) for the Subset of Participants With 2 or More Lines of Prior Systemic Chemotherapy	Progression free survival is defined as the time from the date of the randomization to the first documented disease progression (according to RECIST v1.1) or death due to any cause. The Time frame for Part 2 was up to 29.0 months	Progression Free Survival (PFS) for the subset of participants with 2 or more lines of prior systemic chemotherapy. PFS was based upon RECIST 1.1 assessment, as described in outcome measure 2.
Secondary	Part 2: Overall Survival.	Patients to be contacted every 3 months for up to 12 months (anticipated) for survival follow-up, as well as tumor assessment scans if progression of disease has not previously been documented. The time frame for Part 2 was up to 29.0 months	The number of months from the date of randomization to the date of death.
Secondary	Part 2: Objective Response Rate.	Assessed at 30 days after last dose of study drug; up to 29.0 months for Part 2 of the study	Objective response rate (ORR) is defined as the number and percentage of patients who have a partial response (PR) or complete response (CR) to therapy. A CR is defined 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. A PR is defined as a decrease of at least a 30% in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Secondary	Part 2: Duration of Response	Assessed at 30 days after the last dose of study drug; up to 29.0 months for Part 2 of the study.	Response duration is measured from the time measurement criteria are first met for objective response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study.
Secondary	Part 2: Disease Control Rate.	Assessed at 30 days after last dose of study drug. The time frame for Part 2 was up to 29.0 months	The number and percentage of patients whose disease shrinks or remains stable. DCR is the sum of the complete, partial and stable disease rates.
Other	Part 1: Exploratory PD - Serum BMP9	From randomization up to 21.6 months in Part 1 of the study	Exploratory analysis. Absolute change from baseline in serum Bone Morphogenetic Protein 9 (BMP9)
Other	Part 2: PD Biomarker Activities.	Assessed at 30 days after the last dose of dalantercept ± 10 days. The time frame for Part 2 was up to 29.0 months.	Exploratory analysis. Absolute change from baseline in serum Bone Morphogenetic Protein 9 (BMP9)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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