Trial · NCT01458392
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
NCT01458392, Phase 2, Completed, Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA; results first posted 2017-06-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck. Trials, record NCT01458392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01458392
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
- NCT number
- NCT01458392
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Dalantercept
- First posted
- 2011-10-24
- Last updated
- 2022-10-05
- Results first posted
- 2017-06-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. | ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as the proportion of patients evaluable for response who meet the criteria for complete (CR) and partial response (PR). Per RECIST v1.1 for target lesions and assessed by MRI: complete response (CR), disappearance of all target lesions; partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR + PR. |
| Secondary | Safety and Tolerability | Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept. | Number of participants with at least one adverse event as a measure of safety and tolerability. |
| Secondary | Dalantercept Serum Concentration After Single and Multiple Doses | Up to 43 days from initiation of treatment. | Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is AUC0-t (cycle 1). |
| Secondary | Dalantercept Serum Concentration After Single and Multiple Doses | Up to 43 days from initiation of treatment. | Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is Cmax (cycle 1). |
| Secondary | Progression Free Survival (PFS) | Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. | PFS is defined as the date of the first dose to the first observation of disease progression (according to RECIST v.1.1) or death due to any cause. Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) | Survival captured until death or at a minimum 1 year from first dose of dalantercept. | OS is calculated as the number of months from date of the first dose to the date of death. The last patient treated will be followed for overall survival for 1 year following treatment initiation. |
| Secondary | Disease Control Rate | Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. | Disease control rate will be estimated as the proportion of patients evaluable for response who meet the criteria for complete response, partial response, or stable disease. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. | The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment. | participants | NUMBER |
| SECONDARY | Safety and Tolerability | Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept. | participants | NUMBER | |
| SECONDARY | Dalantercept Serum Concentration After Single and Multiple Doses | Up to 43 days from initiation of treatment. | The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis. | ng*day/mL | GEOMETRIC_MEAN |
| SECONDARY | Dalantercept Serum Concentration After Single and Multiple Doses | Up to 43 days from initiation of treatment. | The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Progression Free Survival (PFS) | Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. | The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | Survival captured until death or at a minimum 1 year from first dose of dalantercept. | The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. | weeks | MEDIAN |
| SECONDARY | Disease Control Rate | Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. | The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment. | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Dalantercept 0.6 mg/kg | 0 | 95% Confidence Interval 0 to 0 | participants | |
| Objective Response Rate (ORR) | Dalantercept 1.2 mg/kg | 2 | 95% Confidence Interval 0.9 to 24.3 | participants | |
| Safety and Tolerability | Dalantercept 80 mg | 2 | participants | ||
| Safety and Tolerability | Dalantercept 0.6 mg/kg | 13 | participants | ||
| Safety and Tolerability | Dalantercept 1.2 mg/kg | 31 | participants | ||
| Dalantercept Serum Concentration After Single and Multiple Doses | Dalantercept 0.6 mg/kg | 32992 | Geometric Coefficient of Variation 35.1 | ng*day/mL | |
| Dalantercept Serum Concentration After Single and Multiple Doses | Dalantercept 1.2 mg/kg | 69572 | Geometric Coefficient of Variation 44.7 | ng*day/mL | |
| Dalantercept Serum Concentration After Single and Multiple Doses | Dalantercept 0.6 mg/kg | 2446 | Geometric Coefficient of Variation 35.1 | ng/mL | |
| Dalantercept Serum Concentration After Single and Multiple Doses | Dalantercept 1.2 mg/kg | 5336 | Geometric Coefficient of Variation 37.8 | ng/mL | |
| Progression Free Survival (PFS) | Dalantercept 0.6 mg/kg | 5.8 | 95% Confidence Interval 5.6 to 11.9 | weeks |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalantercept 80 mg | 2 | |
| Overall Study | STARTED | Dalantercept 0.6 mg/kg | 13 | |
| Overall Study | STARTED | Dalantercept 1.2 mg/kg | 31 | |
| Overall Study | COMPLETED | Dalantercept 80 mg | 0 | |
| Overall Study | COMPLETED | Dalantercept 0.6 mg/kg | 0 | |
| Overall Study | COMPLETED | Dalantercept 1.2 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Dalantercept 80 mg | 2 | |
| Overall Study | NOT COMPLETED | Dalantercept 0.6 mg/kg | 13 | |
| Overall Study | NOT COMPLETED | Dalantercept 1.2 mg/kg | 31 |
Source ClinicalTrials.gov
Adverse events339
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 | Fatigue | General disorders | Dalantercept 80 mg | 1 | 2 | |
| other | Fatigue | General disorders | Dalantercept 0.6 mg/kg | 8 | 13 | |
| other | Fatigue | General disorders | Dalantercept 1.2 mg/kg | 12 | 31 | |
| other | Oedema peripheral | General disorders | Dalantercept 80 mg | 0 | 2 | |
| other | Oedema peripheral | General disorders | Dalantercept 0.6 mg/kg | 2 | 13 | |
| other | Oedema peripheral | General disorders | Dalantercept 1.2 mg/kg | 11 | 31 | |
| other | Face oedema | General disorders | Dalantercept 80 mg | 0 | 2 | |
| other | Face oedema | General disorders | Dalantercept 0.6 mg/kg | 0 | 13 | |
| other | Face oedema | General disorders | Dalantercept 1.2 mg/kg | 5 | 31 | |
| other | Oedema | General disorders | Dalantercept 80 mg | 1 | 2 |
1 to 10 of 339Source ClinicalTrials.gov
See all 339 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalantercept 80 mg | ||
| Total, all-cause mortality | Dalantercept 0.6 mg/kg | ||
| Total, all-cause mortality | Dalantercept 1.2 mg/kg | ||
| Total, other adverse events | Dalantercept 80 mg | 2 | 2 |
| Total, other adverse events | Dalantercept 0.6 mg/kg | 13 | 13 |
| Total, other adverse events | Dalantercept 1.2 mg/kg | 31 | 31 |
| Total, serious adverse events | Dalantercept 80 mg | 1 | 2 |
| Total, serious adverse events | Dalantercept 0.6 mg/kg | 6 | 13 |
| Total, serious adverse events | Dalantercept 1.2 mg/kg | 6 | 31 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dalantercept 0.6 mg/kg vs Dalantercept 1.2 mg/kg: Objective Response Rate (ORR) |
Source 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/NCT01458392
GET https://conductscience.org/api/trials/v1/NCT01458392/events?page=2