ZD6474(Vandetanib) + Alimta Combo Study

Lung Cancer Clinical Trial

Official title:

A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506051
• Other study ID #: D4200C00041
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2007
• Last updated: August 24, 2016
• Start date: July 2005
• Est. completion date: October 2011

Study information

• Verified date: August 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2011
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung

Intervention

Drug:
• ZD6474 (vandetanib) 100mg
once daily oral tablet
• pemetrexed
intravenous infusion
• ZD6474 (vandetanib) 300mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

References & Publications (1)

de Boer R, Humblet Y, Wolf J, Nogová L, Ruffert K, Milenkova T, Smith R, Godwood A, Vansteenkiste J. An open-label study of vandetanib with pemetrexed in patients with previously treated non-small-cell lung cancer. Ann Oncol. 2009 Mar;20(3):486-91. doi: 10.1093/annonc/mdn674. Epub 2008 Dec 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Link
•   CSR-D4200C00041.pdf