ZD6474(Vandetanib) + Alimta Combo Study
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00506051
First received: July 3, 2007
Last updated: November 23, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma Non-Small Cell Lung Lung Cancer |
Drug: ZD6474 (vandetanib) Drug: pemetrexed |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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. [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | July 2005 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: ZD6474 (vandetanib)
once daily oral tablet
Other Name: ZACTIMA™
Drug: pemetrexed
intravenous infusion
Other Name: Alimta®
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00506051 History of Changes |
| Other Study ID Numbers: | D4200C00041 |
| Study First Received: | July 3, 2007 |
| Last Updated: | November 23, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Directorate general for the protection of Public health: Medicines Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AstraZeneca:
|
Non-small cell lung cancer lung cancer alimta vandetanib phase 1 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 19, 2013