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To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer

NCT01284348 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-08-29

Study results available
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Summary

The purpose of this study was to determine an effective and safe dose of sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia (CIA) in participants with metastatic non-small cell lung cancer (NSCLC) who are being treated with first-line platinum based chemotherapy.

Conditions

  • Anemia
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Small-Cell Lung
  • Bladder Cancer
  • Cancer of Head and Neck
  • Uterine Cervical Cancer

Interventions

DRUG

Sotatercept 15 mg

Sotatercept 15 mg SC injection once every 42 days, up to four doses

DRUG

Sotatercept 30 mg

Sotatercept 30 mg SC injection once every 42 days, up to four doses

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-25
Primary Completion
2012-09-21
Completion
2012-09-21

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01284348 on ClinicalTrials.gov