Trial · NCT01727336
Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma
NCT01727336, Phase 2, Terminated, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; results first posted 2021-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma. Trials, record NCT01727336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01727336
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma
- NCT number
- NCT01727336
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 160 participants, actual
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Conditions
- Advanced Renal Cell Carcinoma
- Interventions
- Dalantercept and axitinib, Placebo and axitinib
- First posted
- 2012-11-16
- Last updated
- 2022-10-06
- Results first posted
- 2021-05-24
- Limitations and caveats
All 131 patients in Part 2 discontinued from the study; the most frequent reasons were (i) study terminated at the discretion of the sponsor \[86 patients (65.6%)\] and (ii) death \[36 patients (27.5%)\]. The discontinuations prior to planned sample collections, as outlined in the protocol schedule of events, precluded the ability to carry out all planned analyses, including but not limited to PK analyses. Dalantercept PK in patients with advanced cancer has been reported previously.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Safety Analysis Set (SAF) consisted of all patients who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| 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 | The All Treated Set (ATS) included all randomized patients who received any study drug | Months | MEDIAN |
| SECONDARY | Part 1: Progression Free Survival (PFS). | The time frame for Part 1 of the study was up to 21.6 months | Full Analysis Set; all subjects randomized in Part 1 of the study | Months | MEDIAN |
| 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 | Full Analysis Set; all subjects randomized in Part 1 of the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Objective Response Rate (ORR) | Up to 21.6 months from randomization in Part 1 of the study | Full Analysis Set; all subjects randomized in Part 1 of the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1: Disease Control Rate (DCR) | From randomization up to 21.6 months in Part 1 of the study | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Part 1: Duration of Response (DoR) | From randomization up to 21.6 months in Part 1 of the study. | Full Analysis Set; all subjects randomized in Part 1 of the study | months | MEDIAN |
| 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 | Subgroup of Part 2 participants:~24 of 63 participants in the dalantercept arm and 22 of 68 participants in the placebo arm had at least 2 lines of prior systemic chemotherapy | Months | MEDIAN |
| 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 All Treated Set (ATS) included all randomized patients who received any study drug | Months | MEDIAN |
| 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 | The All Treated Set (ATS) included all randomized patients who received any study drug | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | Part 1 Dalantercept 0.6 mg/kg | 6 | Participants | ||
| Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | Part 1 Dalantercept 0.9 mg/kg | 9 | Participants | ||
| Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | Part 1 Dalantercept 1.2 mg/kg | 14 | Participants | ||
| Part 2: Progression Free Survival (PFS). | Part 2: Dalantercept 0.9 mg/kg Plus Axitinib | 6.8 | 95% Confidence Interval 4.5 to 9.4 | Months | |
| Part 2: Progression Free Survival (PFS). | Part 2: Placebo Plus Axitinib | 5.6 | 95% Confidence Interval 3.3 to 8.3 | Months | |
| Part 1: Progression Free Survival (PFS). | Part 1 Dalantercept 0.6 mg/kg | 5.5 | 95% Confidence Interval 1.3 to 20.6 | Months | |
| Part 1: Progression Free Survival (PFS). | Part 1 Dalantercept 0.9 mg/kg | 21.6 | 95% Confidence Interval 2.8 to 21.6 | Months | |
| Part 1: Progression Free Survival (PFS). | Part 1: Dalantercept 1.2 mg/kg | 6.9 | 95% Confidence Interval 2.7 to 20.7 | Months | |
| Part 1: Overall Survival (OS). [The Time Frame for Part 1 of the Study Was up to 21.6 Months] | Part 1 Dalantercept 0.6 mg/kg | 4 | Participants | ||
| Part 1: Overall Survival (OS). [The Time Frame for Part 1 of the Study Was up to 21.6 Months] | Part 1 Dalantercept 0.9 mg/kg | 7 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 Dalantercept Dose Escalation | STARTED | Part 1 Dalantercept 0.6 mg/kg | 6 | |
| Part 1 Dalantercept Dose Escalation | STARTED | Part 1 Dalantercept 0.9 mg/kg | 9 | |
| Part 1 Dalantercept Dose Escalation | STARTED | Part 1: Dalantercept 1.2 mg/kg | 14 | |
| Part 1 Dalantercept Dose Escalation | STARTED | Part 1: Dalantercept 1.5 mg/kg | 0 | |
| Part 1 Dalantercept Dose Escalation | STARTED | Part 2: Dalantercept 0.9 mg/kg Plus Axitinib | 0 | |
| Part 1 Dalantercept Dose Escalation | STARTED | Part 2: Placebo Plus Axitinib | 0 | |
| Part 1 Dalantercept Dose Escalation | COMPLETED | Part 1 Dalantercept 0.6 mg/kg | 3 | |
| Part 1 Dalantercept Dose Escalation | COMPLETED | Part 1 Dalantercept 0.9 mg/kg | 7 | |
| Part 1 Dalantercept Dose Escalation | COMPLETED | Part 1: Dalantercept 1.2 mg/kg | 6 | |
| Part 1 Dalantercept Dose Escalation | COMPLETED | Part 1: Dalantercept 1.5 mg/kg | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events678
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 | Diarrhoea | Gastrointestinal disorders | Part 1: Dalantercept 0.6 mg/kg | 2 | 6 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Part 1: Dalantercept 0.9 mg/kg | 4 | 9 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Part 1: Dalantercept 1.2 mg/kg | 6 | 14 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Part 1: Dalantercept 1.5 mg/kg | 0 | 0 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Part 2: Dalantercept 0.9 mg/kg Plus Axitinib | 54 | 62 | 54 |
| other | Diarrhoea | Gastrointestinal disorders | Part 2: Placebo Plus Axitinib | 55 | 64 | 55 |
| other | Nausea | Gastrointestinal disorders | Part 1: Dalantercept 0.6 mg/kg | 2 | 6 | 2 |
| other | Nausea | Gastrointestinal disorders | Part 1: Dalantercept 0.9 mg/kg | 3 | 9 | 3 |
| other | Nausea | Gastrointestinal disorders | Part 1: Dalantercept 1.2 mg/kg | 3 | 14 | 3 |
| other | Nausea | Gastrointestinal disorders | Part 1: Dalantercept 1.5 mg/kg | 0 | 0 |
1 to 10 of 678Source ClinicalTrials.gov
See all 678 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Dalantercept 0.6 mg/kg | 2 | 6 |
| Total, all-cause mortality | Part 1: Dalantercept 0.9 mg/kg | 2 | 9 |
| Total, all-cause mortality | Part 1: Dalantercept 1.2 mg/kg | 5 | 14 |
| Total, all-cause mortality | Part 1: Dalantercept 1.5 mg/kg | 0 | 0 |
| Total, all-cause mortality | Part 2: Dalantercept 0.9 mg/kg Plus Axitinib | 20 | 63 |
| Total, all-cause mortality | Part 2: Placebo Plus Axitinib | 16 | 68 |
| Total, other adverse events | Part 1: Dalantercept 0.6 mg/kg | 6 | 6 |
| Total, other adverse events | Part 1: Dalantercept 0.9 mg/kg | 9 | 9 |
| Total, other adverse events | Part 1: Dalantercept 1.2 mg/kg | 14 | 14 |
| Total, other adverse events | Part 1: Dalantercept 1.5 mg/kg | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30951193 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part 2: Dalantercept 0.9 mg/kg Plus Axitinib vs Part 2: Placebo Plus Axitinib: Part 2: Objective Response Rate. | Trial comparisons |
| Part 2: Dalantercept 0.9 mg/kg Plus Axitinib vs Part 2: Placebo Plus Axitinib: Part 2: Disease Control Rate. | 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/NCT01727336
GET https://conductscience.org/api/trials/v1/NCT01727336/results?page=2