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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

Inclusion Criteria:

- Histologically confirmed NSCLC and Stage 3b or 4 NSCLC (Phase 1 only), 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)

- Must have tolerated erlotinib at the maximal dose that will be administered in Phase
2 only (or at a higher dose) for a minimum of 6 weeks

- Measurable disease per RECIST (Phase 2 only)

- At least 18 years old

- ECOG performance status of 0 or 1

- Adequate organ and marrow function

- Sexually active subjects must agree to use medically accepted methods of
contraception during the course of the study and for 3 months following
discontinuation of study treatment (excluding women who are not of child bearing
potential and men who have been sterilized).

- Female subjects of childbearing potential must have a negative pregnancy test at

- No other diagnosis of malignancy (unless non-melanoma skin cancer, carcinoma in situ
of the cervix or malignancy diagnosed ≥ 2 years previously, and currently with no
evidence of disease).

- Capable of understanding and complying with the protocol, and written informed

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:

- 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

- Incapable of understanding and complying with the protocol or unable to provide
informed consent

- History of idiopathic pulmonary fibrosis or interstitial lung disease

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Assessed at each visit

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

December 2012

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Non-Small-Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096
Stanford University Medical Center Stanford, California  94305-5408
Swedish Cancer Institute Seattle, Washington  98104
Katmai Oncology Group Anchorage, Alaska  99508-4627
Case Western Reserve University Cleveland, Ohio  44106
University of Chicago Medical Center Chicago, Illinois  60637
Dana Farber Cancer Institute Boston, Massachusetts  02115
Yale University School Of Medicine New Haven, Connecticut  06520
Park Nicollet Institute St Louis Park, Minnesota  55416
Summit Medical Group Summit, New Jersey  07901
University of California, Davis Sacramento, California  95818
Georgetown University/Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007
University of Washington/ Seattle Cancer Care Alliance Seattle, Washington  98109