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NCT00931606 · ClinicalTrials.gov registry record · Phase 2

Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)

A Phase 2 study, sponsored by Merck Sharp & Dohme.

Terminated
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00931606: Clinical Trial Phase 2 study, sponsored by Merck Sharp & Dohme.

NCT00931606 is a Phase 2 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00931606, a Phase 2 study, was terminated before completion, sponsored by Merck Sharp & Dohme.

TERMINATED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with metastatic breast cancer. Hematopoietic response was defined as an increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of sotatercept in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA).

Primary Outcome

Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.

Interventions

  • DRUG Placebo
  • BIOLOGICAL Sotatercept

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2009-06-01
Est. Completion 2010-11-18
Phase Phase 2
Merck Sharp & Dohme

558 total trials

Why NCT00931606 stopped before completion

NCT00931606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00931606 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00931606 about?

NCT00931606 is a clinical study titled "Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)". The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with me...

What is the current status of trial NCT00931606?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2009-06-01. Estimated completion is 2010-11-18.

What interventions are being tested in trial NCT00931606?

The interventions under investigation include: Placebo (DRUG), Sotatercept (BIOLOGICAL).

Who is sponsoring clinical trial NCT00931606?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00931606's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00931606, the US trial registry maintained by the National Library of Medicine. NCT00931606 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.