Clinical trial · Interventional

ZD6474(Vandetanib) + Alimta Combo Study

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.

NCT00506051CI-TRIAL-00023646completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Carcinoma	Carcinoma	ONTOLOGY_EXACT	0.98
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Non-Small Cell Lung	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
pemetrexed	Drug	Pemetrexed	ALIAS
ZD6474 (vandetanib) 100mg	Drug	Vandetanib	ALIAS
ZD6474 (vandetanib) 300mg	Drug	Vandetanib	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
ZD6474 (vandetanib) 100mg
interventionNames
1. Drug: ZD6474 (vandetanib) 100mg
2. Drug: pemetrexed
type
EXPERIMENTAL
label
ZD6474 (vandetanib) 300mg
interventionNames
1. Drug: pemetrexed
2. Drug: ZD6474 (vandetanib) 300mg

Primary outcomes (1)

measure
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.
timeFrame
assessed at each visit

Secondary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

BACKGROUNDde Boer R, Humblet Y, Wolf J, Nogova 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. PMID 19088171