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KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy

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ClinicalTrials.gov Identifier: NCT01487174
Recruitment Status : Terminated (Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues)
First Posted : December 7, 2011
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

December 2, 2011
December 7, 2011
July 24, 2014
November 2011
June 2013   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year ]
Same as current
Complete list of historical versions of study NCT01487174 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year ]
  • Number and type of adverse events related to KD019 [ Time Frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year ]
    For the purpose of data collection, all untoward events that occur after informed consent through 30 days after last dose of study treatment are to be recorded.
  • Objective response rate [ Time Frame: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year ]
Same as current
Not Provided
Not Provided
 
KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy
A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: KD019
    KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
    Other Name: XL647
  • Drug: Erlotinib
    Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
    Other Name: Tarceva
  • Experimental: KD019
    KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
    Intervention: Drug: KD019
  • Active Comparator: Erlotinib
    Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
    Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
620
May 2014
June 2013   (Final data collection date for primary outcome measure)

For Eligibility subjects must have:

  • failed one or two previous courses of therapy.
  • have no active brain metastasis. Treated non-active brain metastasis are acceptable.
  • cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva [erlotinib] or Iressa [gefitinib]) in the past.
  • has demonstrated progressive disease.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01487174
KD019-301
Not Provided
Not Provided
Not Provided
Kadmon Corporation, LLC
Kadmon Corporation, LLC
Not Provided
Not Provided
Kadmon Corporation, LLC
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP