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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: KD019 Drug: Erlotinib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KD019
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
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

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.
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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.

  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487174


Locations
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06519
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
Sponsors and Collaborators
Kadmon Corporation, LLC

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT01487174     History of Changes
Other Study ID Numbers: KD019-301
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action