ZD6474(Vandetanib) + Alimta Combo Study

Genzyme

Status and phase: Completed; Phase 1

Conditions: Non-Small Cell Lung; Lung Cancer; Carcinoma

Treatments: Drug: pemetrexed; Drug: ZD6474 (vandetanib) 300mg; Drug: ZD6474 (vandetanib) 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00506051

D4200C00041

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

ZD6474 (vandetanib) 100mg

Experimental group

Treatment:

Drug: ZD6474 (vandetanib) 100mg

Drug: pemetrexed

ZD6474 (vandetanib) 300mg

Experimental group

Treatment:

Drug: ZD6474 (vandetanib) 300mg

Drug: pemetrexed