ZD6474(Vandetanib) + Alimta Combo Study
Phase 1
Completed
- Conditions
- CarcinomaNon-Small Cell LungLung Cancer
- Interventions
- Registration Number
- NCT00506051
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Confirmed advanced or metastatic non-small cell lung cancer
- Failure of first-line chemotherapy
- 1 or more measurable lesion by RECIST
Exclusion Criteria
- Previous chemotherapy or radiotherapy within 4 weeks
- Significant cardiac events, arrythmias or other cardiac conditions
- Unacceptable laboratory measurements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ZD6474 (vandetanib) 100mg ZD6474 (vandetanib) 100mg - ZD6474 (vandetanib) 100mg pemetrexed - ZD6474 (vandetanib) 300mg pemetrexed - ZD6474 (vandetanib) 300mg ZD6474 (vandetanib) 300mg -
- Primary Outcome Measures
Name Time Method To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam. assessed at each visit
- Secondary Outcome Measures
Name Time Method To investigate the pharmacokinetics of ZD6474 and Pemetrexed when given in combination to patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy, by assessment of appropriate pharmacokinetic (PK) parameters. assessed at each visit