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

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Exelixis
Study ID
NCT00596648
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XL184 — DRUG
    Capsules administered orally daily
  • erlotinib — DRUG
    Tablets administered orally daily.

Study Details

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.

Key Dates

First listed
Jan 17, 2008
Start date
Feb 12, 2008
Status verified
Dec 2025
Primary completion
Aug 2, 2012
Completion
Aug 2, 2012

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Arm
    Escalating doses of XL184 + erlotinib
  • Experimental: Phase 2 Arm 1
    XL184 + erlotinib (dose determined from Phase 1 portion of study)
  • Experimental: Phase 2 Arm 2
    XL184 administered as a single agent

Primary Outcome Measure

Phase 1: Duration of Exposure of Cabozantinib With Erlotinib [ Time Frame: From initial dose up to 160 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Katmai Oncology GroupAnchorageAlaska99508-
Stanford University Medical CenterPalo AltoCalifornia94305-
University of California, DavisSacramentoCalifornia95817-
Yale University School of MedicineNew HavenConnecticut06520-
Georgetown University/Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
University of Chicago Medical CenterChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Park Nicollet InstituteSaint Louis ParkMinnesota55416-
Summit Medical GroupBerkeley HeightsNew Jersey07922-
Case Western Reserve UniversityClevelandOhio44106-
MD Anderson Cancer CenterHoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-
University of Washington/ Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Anchorage, AK

By research site
Katmai Oncology Group· Anchorage, AKStanford University Medical Center· Palo Alto, CAUniversity of California, Davis· Sacramento, CAYale University School of Medicine· New Haven, CTGeorgetown University/Lombardi Comprehensive Cancer Center· Washington D.C., DCUniversity of Chicago Medical Center· Chicago, IL

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