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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327535
• Other study ID #: NH19960
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2006
• Last updated: August 9, 2016
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 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/kg 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Darbepoetin alfa
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
• methoxy polyethylene glycol-epoetin beta [Mircera]
6.3 micrograms/kg every 3 weeks
• methoxy polyethylene glycol-epoetin beta [Mircera]
9 micrograms/kg every 3 weeks
• methoxy polyethylene glycol-epoetin beta [Mircera]
12 micrograms/kg every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Canada,  Czech Republic,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Hb change from baseline		Weeks 5-13	No
Secondary	Target Hb therapeutic range, average Hb values, hematopoietic response.		Days 2-85	No
Secondary	Red blood cell (RBC) transfusions		Weeks 5-13	No
Secondary	Adverse events (AEs), laboratory parameters, premature withdrawals		Throughout study	No