A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)

Trial ID or NCT#

NCT00596648

Status

not recruiting iconNOT RECRUITING

Purpose

The study consisted of a Phase 1 dose escalation/dose de-escalation portion to determine a safe and tolerable combination dose(s) of cabozantinib and erlotinib, and a Phase 2 Simon optimal 2-stage design portion with randomized assignment of subjects in an equal ratio to determine the objective response rate (ORR) of cabozantinib with or without erlotinib in subjects with non-small cell lung cancer (NSCLC) who have progressed after responding to treatment with erlotinib. The doses of cabozantinib used in this study were based on the salt weight, not the freebase weight.

Official Title

A Phase 1b/2 Study of XL184 With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Exclusion Criteria:
  1. * Received anti-cancer treatment within 4 weeks, except erlotinib, prior to first dose (Phase 1 only)* In Phase 2 only: the subject has received:
  2. * Small molecule inhibitors of VEGFR2/KDR OR * An investigational anti-cancer agent within 4 weeks of the first dose of study drug OR * An investigational agent that targets EGF or EGFR at any time OR * An approved agent that targets EGF or EGFR (with the exception of erlotinib and gefitinib) at any time unless approved by Exelixis OR * Anti-cancer therapy within 4 weeks (with the exception of gefitinib and erlotinib) of the first dose of study drug OR * Prior therapy with a c-Met inhibitor* Not recovered to NCI CTCAE v.3 Grade ≤1 from clinically significant adverse events due to antineoplastic agents, investigational drugs, or other medications administered prior to study enrollment* Symptomatic or uncontrolled brain metastases requiring current treatment, including steroids and anticonvulsants* History of significant hematemesis or recent history of hemoptysis* Presence of cavitation, central lesion, or lesion abutting a major blood vessel* Intercurrent illness such as hypertension or cardiac arrhythmias or recent history of significant disease such as congestive heart failure* Pregnant or breastfeeding* Active bacterial or viral infection requiring systemic treatment* Allergy or hypersensitivity to components of either the XL184 or erlotinib formulations* Incapable of understanding and complying with the protocol or unable to provide informed consent* History of idiopathic pulmonary fibrosis or interstitial lung disease
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Investigator(s)

Heather A Wakelee
Heather A Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor

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Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov