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ZD6474(Vandetanib) + Alimta Combo Study

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma; Non-Small Cell Lung; Lung Cancer

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

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Richard deBoer, MD, Principal Investigator, Affiliation: Western Hospital Footscray, Victoria, Australia
Peter Langmuir, Study Director, Affiliation: AstraZeneca

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.

Clinical Details

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.

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

Primary outcome: 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.

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

CSR-D4200C00041.pdf

Related publications:

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.

Starting date: July 2005
Last updated: March 23, 2015

Page last updated: August 20, 2015

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