A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00327535
First received: May 16, 2006
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This 4 arm study will assess the optimal starting dose of Mircera in the treatme nt of anemia in patients with non-small cell lung cancer receiving first line my elosuppressive chemotherapy. Patients will be randomized to receive either Mirce ra 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/k g s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.


Condition Intervention Phase
Anemia
Drug: Darbepoetin alfa
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Average Hb change from baseline [ Time Frame: Weeks 5-13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target Hb therapeutic range, average Hb values, hematopoietic response. [ Time Frame: Days 2-85 ] [ Designated as safety issue: No ]
  • RBC transfusions [ Time Frame: Weeks 5-13 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, premature withdrawals [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: May 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
6.3 micrograms/kg every 3 weeks
Experimental: 2 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
9 micrograms/kg every 3 weeks
Experimental: 3 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
12 micrograms/kg every 3 weeks
Active Comparator: 4 Drug: Darbepoetin alfa
6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week
Other Name: Mircera

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >=18 years of age;
  • stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy;
  • myelosuppressive chemotherapy scheduled for at least 9 weeks;
  • anemia at screening visit.

Exclusion Criteria:

  • transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication;
  • iron deficiency anemia, or anemia caused by gastrointestinal bleeding;
  • prior treatment with Mircera.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327535

  Show 68 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00327535     History of Changes
Other Study ID Numbers: NH19960
Study First Received: May 16, 2006
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Darbepoetin alfa
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014