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CompletedNCT01458392Updated Oct 5, 2022Results posted

Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck

A Phase 2 interventional study of Dalantercept in Squamous Cell Carcinoma of the Head and Neck, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-05.

Sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks the development of blood vessels that supply tumors.

Read the detailed description

For cancer cells to grow, they need to have nutrients supplied to them through blood vessels. The study drug, dalantercept, is designed to work by blocking the growth of those blood vessels and preventing cancer cells from growing. The purpose of this study is to find out if dalantercept can cause SCCHN tumors to shrink or stop growing. This study will also evaluate the safety of dalantercept in patients with SCCHN.

02

Conditions studied

  • Squamous Cell Carcinoma of the Head and Neck
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 46 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA is the lead sponsor of 25 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Histologically and/or cytologically confirmed, recurrent or metastatic SCCHN of mucosal origin (oral cavity, oropharynx, hypopharynx or larynx) not amenable to further local therapy (surgery, or radiation including re-irradiation); patients with unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if they meet all other entry criteria.
  • Previously treated with at least one platinum-containing regimen or contraindicated for treatment with a platinum containing therapy. (Note: platinum therapy can occur upfront or after recurrence of disease. Failure of platinum therapy is not required.)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

  • Nasopharyngeal carcinoma, paranasal sinus, salivary gland or primary skin SCCHN.
  • Any other active malignancy for which chemotherapy or other anti-cancer therapy is indicated.
  • Chemotherapy or other anti-cancer therapy or radiation therapy within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known.
  • Treatment with another investigational drug or device, or approved therapy for investigational use, within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known.
  • Major surgery within 4 weeks prior to study day 1 (patients must have recovered completely from any previous surgery prior to study day 1).
  • Clinically significant cardiovascular risk.
  • Clinically significant active pulmonary risk.
  • Clinically significant active bleeding.
  • Peripheral edema ≥ Grade 1 within 4 weeks prior to study day 1.
  • Pregnant or lactating female patients.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Dalantercept

    dalantercept

    Biological: Dalantercept

Interventions

  • BiologicalDalantercept

    Subcutaneous dose of dalantercept once every 3 weeks.

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    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.

    Time frame: 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.

Secondary outcomes

  1. Safety and Tolerability

    Number of participants with at least one adverse event as a measure of safety and tolerability.

    Time frame: Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept.

  2. Dalantercept Serum Concentration After Single and Multiple Doses

    Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is AUC0-t (cycle 1).

    Time frame: Up to 43 days from initiation of treatment.

  3. Dalantercept Serum Concentration After Single and Multiple Doses

    Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is Cmax (cycle 1).

    Time frame: Up to 43 days from initiation of treatment.

  4. Progression Free Survival (PFS)

    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.

    Time frame: 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.

  5. Overall Survival (OS)

    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.

    Time frame: Survival captured until death or at a minimum 1 year from first dose of dalantercept.

  6. Disease Control Rate

    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.

    Time frame: 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.

07

Results

Posted Jun 27, 2017

Participant flow

Participant flow — Overall Study
MilestoneDalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Started21331
Completed000
Not completed21331
Withdrew: Death21122
Withdrew: At the discretion of the sponsor027
Withdrew: Patient unwilling to comply with protoco002

Outcome measures

PrimaryObjective Response Rate (ORR)

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.

Time frame:
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.
Reported as:
Number · participants
Objective Response Rate (ORR)
participantsDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Objective Response Rate (ORR)0 (0 to 0)2 (0.9 to 24.3)
SecondarySafety and Tolerability

Number of participants with at least one adverse event as a measure of safety and tolerability.

Time frame:
Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept.
Reported as:
Number · participants
Safety and Tolerability
participantsDalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Safety and Tolerability21331
SecondaryDalantercept Serum Concentration After Single and Multiple Doses

Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is AUC0-t (cycle 1).

Time frame:
Up to 43 days from initiation of treatment.
Reported as:
Geometric mean · ng*day/mL
Dalantercept Serum Concentration After Single and Multiple Doses
ng*day/mLDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Dalantercept Serum Concentration After Single and Multiple Doses32992 ± 35.169572 ± 44.7
SecondaryDalantercept Serum Concentration After Single and Multiple Doses

Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is Cmax (cycle 1).

Time frame:
Up to 43 days from initiation of treatment.
Reported as:
Geometric mean · ng/mL
Dalantercept Serum Concentration After Single and Multiple Doses
ng/mLDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Dalantercept Serum Concentration After Single and Multiple Doses2446 ± 35.15336 ± 37.8
SecondaryProgression Free Survival (PFS)

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.

Time frame:
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.
Reported as:
Median · weeks
Progression Free Survival (PFS)
weeksDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Progression Free Survival (PFS)5.8 (5.6 to 11.9)6.1 (5.7 to 11.7)
SecondaryOverall Survival (OS)

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.

Time frame:
Survival captured until death or at a minimum 1 year from first dose of dalantercept.
Reported as:
Median · weeks
Overall Survival (OS)
weeksDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Overall Survival (OS)30.9 (13.6 to 45.6)41.3 (23.9 to 69.4)
SecondaryDisease Control Rate

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.

Time frame:
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.
Reported as:
Number · percentage of participants
Disease Control Rate
percentage of participantsDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Disease Control Rate30.8 (9.1 to 61.4)44.4 (25.5 to 64.7)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dalantercept 80 mg—1/2 (50%)2/2 (100%)
Dalantercept 0.6 mg/kg—6/13 (46.2%)13/13 (100%)
Dalantercept 1.2 mg/kg—6/31 (19.4%)31/31 (100%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventDalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
Tongue cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/20/130/31
Pleural effusionRespiratory, thoracic and mediastinal disorders0/21/131/31
AspirationRespiratory, thoracic and mediastinal disorders0/21/130/31
Respiratory distressRespiratory, thoracic and mediastinal disorders0/21/130/31
Disease progressionGeneral disorders0/21/132/31
Metastases to central nervous systemNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/21/130/31
Spinal cord compressionNervous system disorders0/21/130/31
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders0/20/131/31
Pulmonary oedemaRespiratory, thoracic and mediastinal disorders0/20/131/31
Tumour compressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/20/131/31
Most frequent other events
Showing 10 of 99
Most frequent other events
EventDalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kg
FatigueGeneral disorders1/28/1312/31
AnaemiaBlood and lymphatic system disorders0/22/1316/31
OedemaGeneral disorders1/22/131/31
HeadacheNervous system disorders1/24/1311/31
ConstipationGastrointestinal disorders1/23/132/31
NauseaGastrointestinal disorders1/21/134/31
VomitingGastrointestinal disorders1/22/133/31
DiarrhoeaGastrointestinal disorders1/21/130/31
LymphadenopathyBlood and lymphatic system disorders1/20/130/31
HyponatraemiaMetabolism and nutrition disorders1/21/139/31

Baseline characteristics

Age, Continuous
Age, Continuous(years)Dalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kgTotal
Mean56.5 ± 13.459.6 ± 5.161.1 ± 9.560.5 ± 8.5
Sex: Female, Male
Sex: Female, Male(Participants)Dalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kgTotal
Female2057
Male0132639
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kgTotal
Hispanic or Latino0202
Not Hispanic or Latino2113144
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kgTotal
American Indian or Alaska Native0000
Asian0033
Native Hawaiian or Other Pacific Islander0000
Black or African American0077
White2131934
More than one race0000
Unknown or Not Reported0022
Region of Enrollment
Region of Enrollment(participants)Dalantercept 80 mgDalantercept 0.6 mg/kgDalantercept 1.2 mg/kgTotal
United States2133146
08

Study locations

8 sites
  • Acceleron Investigative Site
    Aurora, Colorado, United States
  • Acceleron Investigative Site
    Atlanta, Georgia, United States
  • Acceleron Investigative Site
    Boston, Massachusetts, United States
  • Acceleron Investigative Site
    Detroit, Michigan, United States
  • Acceleron Investigative Site
    New York, New York, United States
  • Acceleron Investigative Site
    Philadelphia, Pennsylvania, United States
  • Acceleron Investigative Site
    San Antonio, Texas, United States
  • Acceleron Investigative Site
    Salt Lake City, Utah, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01458392
Lead sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Responsible party
Sponsor
First posted
Oct 24, 2011
Start date
Oct 2011
Primary completion
Jun 2015
Completion
Sep 2015
Results posted
Jun 27, 2017
Last update
Oct 5, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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