Heather Wakelee
A Study of XL184 With or Without Erlotinib in Adults With Non-Small Cell Lung Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
In Phase 1 of this study, the purpose is to evaluate the safety, tolerability, and highest safe dose of the multiple receptor tyrosine kinase inhibitor (including VEGFR2, MET, and RET) XL184 in combination with the EGFR inhibitor erlotinib administered to adults with Non-Small-Cell Lung Cancer (NSCLC). In Phase 2 of this study, the purpose is to evaluate the objective response rate of daily oral administration of XL184 with or without erlotinib in subjects with NSCLC who have progressed after responding to treatment with erlotinib. Target enrollment of Phase 1 is approximately 18 subjects, and target enrollment in Phase 2 is up to 68 subjects (34 subjects in each arm).
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: XL184
- Drug: erlotinib
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Histologically confirmed NSCLC and Stage 3b or 4 NSCLC (Phase 1 only) or Stage 3a with pleural effusion, Stage 3b or 4 NSCLC (Phase 2 only)
- Documented progressive disease following a prior RECIST response to monotherapy with erlotinib OR documented progressive disease following stable disease of at least 6 months on monotherapy with erlotinib (Phase 2 only)
- Measurable disease per RECIST (Phase 2 only)
- At least 18 years old
- Life expectancy greater than 3 months
- ECOG performance status of 0 or 1
- Adequate organ and marrow function
- Capable of understanding and complying with the protocol, and written informed consent
- Female subjects of childbearing potential must have a negative pregnancy test at enrollment
Key Exclusion Criteria:
- Received anti-cancer treatment within 4 weeks, except erlotinib, prior to first dose (Phase 1 only)
- In Phase 2 only: the subject has received:
o Radiation to >=25% of his or her bone marrow within 4 weeks of the first dose of study drug OR
o Small molecule inhibitors of VEGFR2/KDR OR
o An investigational anti-cancer agent within 4 weeks of the first dose of study drug OR
o An investigational agent that targets EGF or EGFR at any time OR
o An approved agent that targets EGF or EGFR (with the exception of erlotinib and gefitinib) at any time unless approved by Exelixis OR
o Anti-cancer therapy within 4 weeks (with the exception of gefitinib and erlotinib) of the first dose of study drug OR
o Concurrent radiation treatment
- Not recovered to NCI CTCAE v.3 Grade <=1 from 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
- 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
Additional Study Details
Official Title:
A Phase 1/2 Study of XL184 With or Without Erlotinib in Subjects With Non-Small Cell Lung CancerAnticipated start date:
7/17/2008Lead Sponsor:
ExelixisInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- In Phase 1 of the study: evaluate safety, tolerability, and maximum tolerated dose of daily oral administration of XL184 in combination with erlotinib to subjects with NSCLC
- In Phase 1 of the study, to evaluate pharmacodynamic effects of XL184 administration either alone or in combination with erlotinib
- In Phase 1 of the study, to characterize pharmacokinetic parameters of single agent erlotinib, and of XL184 in combination with erlotinib
- In Phase 2 of the study, to estimate the objective response rate of XL184 with or without erlotinib in adults with NSCLC who have progressed after responding to erlotinib
- In Phase 2 of the study, to assess pharmacodynamic effects of XL184 administration either alone or with erlotinib
- In Phase 2 of the study, to characterize pharmacokinetic parameters of XL184 as a single agent and XL184 in combination with erlotinib in subjects with NSCLC
Secondary Outcomes:
- In Phase 1 of the study, to assess response rate, progression-free survival, duration of response, and overall survival in subjects with NSCLC following treatment with XL184 either alone or in combination with erlotinib
- In Phase 2 of the study, to evaluate the long-term safety and tolerability of XL184 administered either alone or in combination with erlotinib
- In Phase 2 of the study, to assess progression-free survival, duration of response, and overall survival following treatment with XL184 either alone or in combination with erlotinib
Total Number to be Enrolled:
86Total Number to be Enrolled at Stanford:
27More Information
Secondary ID(s):
- LUN0027
- NCT00596648
- XL184-202
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/19/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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