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 | Terminated Phase 2 Results DMC

• 3 other identifiers: 7962-015ACE-011-NSCL-0012010-022561-10
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Chemotherapy induced anemia; Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced a Hematopoietic Response

  A hematopoietic response was defined as an increase in a participant's hemoglobin (Hgb) of ≥1.0 g/dL above the study baseline value for 4 consecutive weeks, in the absence of red blood cell transfusion and/or erythropoiesis-stimulating agents.

  Up to Day 28

Secondary Outcomes (13)

• Number of Participants Who Experienced One or More Adverse Events (AEs)

  Up to approximately 6 months

• Time to Progression (TTP)

  Up to 6 months

• Progression Free Survival (PFS)

  Up to 12 months

• Overall Survival (OS)

  Up to 24 months

• Overall Response Rate (ORR)

  Up to 12 months

Study Arms (2)

Sotatercept 15 mg

EXPERIMENTAL

Participants will receive sotatercept 15 mg by subcutaneous (SC) injection once every 42 days, up to four doses.

Drug: Sotatercept 15 mg

Sotatercept 30 mg

EXPERIMENTAL

Participants will receive sotatercept 30 mg by SC injection once every 42 days, up to four doses.

Drug: Sotatercept 30 mg

Interventions

Sotatercept 15 mg DRUG

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

Also known as: ACE-011

Sotatercept 15 mg

Sotatercept 30 mg DRUG

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

Also known as: ACE-011

Sotatercept 30 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women \>18 years of age
• Part 1: Histologically confirmed (cytology or biopsy) solid tumor malignancy, excluding those solid tumors treated with curative intent.
• Part 2: Histologically confirmed non-small cell lung cancer
• Documented metastatic disease
• Measurable or non-measurable disease evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
• All of the following laboratory values:
• Hemoglobin ≥6.5 to \<11.0 g/dL (≥65 to \<110 g/L), due to chemotherapy-induced anemia
• Absolute neutrophil count ≥500/mm\^3
• Platelet count ≥75,000/mm\^3 (\>2 hours since prior platelet transfusion
• Adequate renal function
• creatinine clearance ≥40mL/min or ≥50 mL/min if cisplatin is concomitantly administered and
• urine protein / creatinine ratio ≤1.0; or ≤2.0 if bevacizumab (Avastin®) is concomitantly administered
• Hepatic function (bilirubin \<1.5 x upper limits of normal (ULN); AST and ALT \<3.0 x ULN and ≤5.0 ULN for participants with liver metastases)
• Participants must have received:
• at least one cycle and up to 4 cycles (q3w schedule) of platinum-based chemotherapy and be randomized prior to receiving Cycle 5 OR

You may not qualify if:

• Part 2 only, history of prior regimen(s)of platinum-based chemotherapy for metastatic NSCLC and/or history of adjuvant platinum-based chemotherapy with last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic NSCLC.
• National Cancer Institute Common Terminology for Adverse Events Grade \>3 toxicity
• Prior radiation to \>20% of whole skeleton
• Prior regimen(s) of platinum based chemotherapy for metastatic disease and/or history of adjuvant platinum-based chemotherapy with the last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic disease
• Central nervous system metastases
• Clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic, or genitourinary disease unrelated to underlying malignancy
• Classification of 3 or higher heart failure (as classified by New York Heart Association)
• History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke, if not stable on anticoagulants and/or one of these events occurring in past 6 months
• Diagnosis of a myeloid malignancy or known history of myelodysplasia
• Recent history (within 14 days of Day 1) of IV/oral antibiotics due to post septic episode
• Uncontrolled hypertension. Controlled hypertension is considered clinically stable, and systolic blood pressure (SBP) must be \<150 mmHg and diastolic blood pressure (DBP) must be \< 00 mmHg.
• Known human immunodeficiency virus (HIV)
• Known active hepatitis B or C antibody
• Iron deficiency
• History of anemia as a result of inherited hemoglobinopathy

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Raftopoulos H, Laadem A, Hesketh PJ, Goldschmidt J, Gabrail N, Osborne C, Ali M, Sherman ML, Wang D, Glaspy JA, Puccio-Pick M, Zou J, Crawford J. Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer or advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens: results from two phase 2 studies. Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 2015 Sep 14.

  PMID: 26370220 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Anemia; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Urinary Bladder Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: January 27, 2011
• Study Start: March 25, 2011
• Primary Completion: September 21, 2012
• Study Completion: September 21, 2012
• Last Updated: August 29, 2024
• Results First Posted: October 31, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share