Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy in Non-small Cell Lung Cancer (NSCLC)

Conditions

• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• imetelstat — DRUG
  9.4 mg/kg over a 2 hour IV infusion on Day 1 and Day 8 of each 21 day cycle until disease progression.
• Bevacizumab — DRUG
  Dosage and duration will be according to the FDA-approved bevacizumab package insert. Bevacizumab will be administered on Day 1 of each 21-day cycle.

Study Details

The purpose of this is to evaluate the efficacy and safety of imetelstat (GRN163L) as maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4 cycles of platinum based therapy. Participants will be randomized in a 2:1 ratio to imetelstat + standard of care versus standard of care alone. Participants who received bevacizumab with their induction chemotherapy will continue to receive bevacizumab on this study.

Key Dates

First listed

Jun 7, 2010

Start date

May 31, 2010

Status verified

Mar 2015

Primary completion

Sep 30, 2013

Completion

Sep 30, 2013

Study Design

Enrollment

116 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: imetelstat plus standard of care
  imetelstat plus standard of care (bevacizumab or observation)
• Other: Standard of care
  Bevacizumab or observation

Primary Outcome Measure

Progression-free survival [ Time Frame: From randomization to documented disease progression or death, whichever occurs earlier, through the end of the study period (8 mos. after the last participant is randomized) ]

Locations (26)

Find similar trials in Birmingham, AL

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