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Study of Tesevatinib in Subjects With Non-Small Cell Lung Cancer, EGFR Activating Mutation, Prior Treatment With a Tyrosine Kinase Inhibitor, and Brain Metastases or Leptomeningeal Metastases

This study is currently recruiting participants.
Verified March 2017 by Kadmon Corporation, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02616393
First Posted: November 26, 2015
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kadmon Corporation, LLC
November 20, 2015
November 26, 2015
March 3, 2017
November 2015
June 2017   (Final data collection date for primary outcome measure)
  • Clinical Activity of tesevatinib against BM using RECIST 1.1 [ Time Frame: 12 months ]
    The primary objective is to evaluate the clinical activity of tesevatinib in subjects with non-small cell lung cancer (NSCLC), activating EGFR mutations, and BM as measured by RECIST 1.1 evaluated changes in BM size (Cohort A)
  • Clinical Activity of tesevatinib against LM using Symptom Resolution [ Time Frame: 12 months ]
    The primary objective is to evaluate the clinical activity of tesevatinib in subjects with NSCLC, activating EGFR mutations and/or LM as measured by improvement in CTCAE v4.03 symptoms and signs (Cohort B)
  • Clinical Activity of tesevatinib against BM at initial presentation using RECIST 1.1 [ Time Frame: 12 months ]
    The primary objective is to evaluate the clinical activity of tesevatinib in subjects with non-small cell lung cancer (NSCLC), activating EGFR mutations, and BM at initial presentation as measured by RECIST 1.1 evaluated changes in BM size (Cohort C)
  • Clinical Activity of tesevatinib against BM using RECIST 1.1 [ Time Frame: 12 months ]
    The primary objective is to evaluate the clinical activity of tesevatinib in subjects with non-small cell lung cancer (NSCLC), activating EGFR mutations, and BM as measured by RECIST 1.1 evaluated changes in BM size (Cohort A)
  • Clinical Activity of tesevatinib against LM using Symptom Resolution [ Time Frame: 12 months ]
    The primary objective is to evaluate the clinical activity of tesevatinib in subjects with NSCLC, activating EGFR mutations and/or LM as measured by improvement in CTCAE v4.03 symptoms and signs (Cohort B)
Complete list of historical versions of study NCT02616393 on ClinicalTrials.gov Archive Site
  • Quality of Life in Subjects Receiving tesevatinib for BM [ Time Frame: 12 months ]
    To evaluate changes in Quality of Life (QOL) in subjects receiving tesevatinib for BM using the EORTC QLQ-C30 and EORTC QLQ-BN20 Questionnaires
  • Quality of Life in Subjects Receiving tesevatinib for LM [ Time Frame: 12 months ]
    To evaluate changes in QOL in subjects receiving tesevatinib for LM using the EORTC QLQ-C30 and EORTC QLQ-BN20 Questionnaires
  • Quality of Life in Subjects Receiving tesevatinib for BM at initial presentation [ Time Frame: 12 months ]
    To evaluate changes in QOL in subjects receiving tesevatinib for BM at initial presentation using the EORTC QLQ-C30 and EORTC QLQ-BN20 Questionnaires
  • Median Progression-Free Survival in Cohort A [ Time Frame: 12 months ]
    To determine the median progression-free survival (PFS) in Cohort A by assessing the median number of days from Cycle 1, Day 1 until disease progression or death
  • Rate of CNS Non-Progression in Cohort A [ Time Frame: 12 months ]
    To determine the rate of CNS non-progression at 3 and 6 months Cohort A by assessing the percentage of subjects in Cohort A without CNS disease progression 3 and 6 months after Cycle 1, Day 1
  • Non-CNS Time to Progression in Cohort A [ Time Frame: 12 months ]
    To determine the rate of Non-CNS time to progression in Cohort A by assessing the median number of days in Cycle 1, Day 1 until non-CNS disease progression
  • CNS TTP in Cohort A [ Time Frame: 12 months ]
    To determine the rate of CNS TTPin Cohort A by assessing the median number of days in Cycle 1, Day 1 to disease progression
  • Median Progression-Free Survival in Cohort B [ Time Frame: 12 months ]
    To determine the median progression-free survival (PFS) in Cohort B by assessing the median number of days from Cycle 1, Day 1 until disease progression or death
  • Rate of CNS Non-Progression in Cohort B [ Time Frame: 12 months ]
    To determine the rate of CNS non-progression at 3 and 6 months Cohort B by assessing the percentage of subjects in Cohort A without CNS disease progression 3 and 6 months after Cycle 1, Day 1
  • Non-CNS Time to Progression in Cohort B [ Time Frame: 12 months ]
    To determine the rate of Non-CNS time to progression in Cohort B by assessing the median number of days in Cycle 1, Day 1 until non-CNS disease progression
  • CNS TTP in Cohort B [ Time Frame: 12 months ]
    To determine the rate of CNS TTP in Cohort B by assessing the median number of days in Cycle 1, Day 1 to disease progression
  • Median Overall Survival in Cohort A [ Time Frame: 12 months ]
    To determine the median overall survival (OS) in Cohort A by measuring the median number of days from Cycle 1, Day 1 until death
  • Median Overall Survival in Cohort B [ Time Frame: 12 months ]
    To determine the median OS in Cohort B by measuring the median number of days from Cycle 1, Day 1 until death
  • Clinical Activity of tesevatinib against LM using Standard Cytology [ Time Frame: 12 months ]
    Evaluate the activity of tesevatinib in subjects with NSCLC as measured by decreases in NSCLC cells in the CSF using standard cytology as assessed by the percent change in the number of NSCLC cells in the CSF for each patient in cohort B from screening to Cycle 1, Day 14, from Day 14 to Cycle 3, Day 1, and from screening to Cycle 3, Day 1 (Cohort B)
  • Clinical Activity of tesevatinib against LM using Improvement in MRI Findings [ Time Frame: 12 months ]
    Evaluate the activity of tesevatinib in subjects with NSCLC as measured by changes in MRI findings consistent with leptomeningeal metastases (absent or present) for each patient in Cohort B from Cycle 1, Day 1 to Cycle 3, Day 1 and from Cycle 1, Day 1 to Cycle 5 Day 1 (Cohort B)
  • Pharmacokinetics [ Time Frame: 12 months ]
    To evaluate the concentration of tesevatinib in CSF versus plasma (Cohort B)
  • Median Progression-Free Survival in Cohort C [ Time Frame: 12 months ]
    To determine the median progression-free survival (PFS) in Cohort C by assessing the median number of days from Cycle 1, Day 1 until disease progression or death
  • Rate of CNS Non-Progression in Cohort C [ Time Frame: 12 months ]
    To determine the rate of CNS non-progression at 3 and 6 months Cohort C by assessing the percentage of subjects in Cohort C without CNS disease progression 3 and 6 months after Cycle 1, Day 1
  • Non-CNS Time to Progression in Cohort C [ Time Frame: 12 months ]
    To determine the rate of Non-CNS time to progression in Cohort C by assessing the median number of days in Cycle 1, Day 1 until non-CNS disease progression
  • CNS TTP in Cohort C [ Time Frame: 12 months ]
    To determine the rate of CNS TTPin Cohort C by assessing the median number of days in Cycle 1, Day 1 to disease progression
  • Median Overall Survival in Cohort C [ Time Frame: 12 months ]
    To determine the median overall survival (OS) in Cohort C by measuring the median number of days from Cycle 1, Day 1 until death
  • Quality of Life in Subjects Receiving tesevatinib for BM [ Time Frame: 12 months ]
    To evaluate changes in Quality of Life (QOL) in subjects receiving tesevatinib for BM using the EORTC QLQ-C30 and EORTC QLQ-BN20 Questionnaires
  • Quality of Life in Subjects Receiving tesevatinib for LM [ Time Frame: 12 months ]
    To evaluate changes in QOL in subjects receiving tesevatinib for LM using the EORTC QLQ-C30 and EORTC QLQ-BN20 Questionnaires
  • Median Progression-Free Survival in Cohort A [ Time Frame: 12 months ]
    To determine the median progression-free survival (PFS) in Cohort A by assessing the median number of days from Cycle 1, Day 1 until disease progression or death
  • Rate of CNS Non-Progression in Cohort A [ Time Frame: 12 months ]
    To determine the rate of CNS non-progression at 3 and 6 months Cohort A by assessing the percentage of subjects in Cohort A without CNS disease progression 3 and 6 months after Cycle 1, Day 1
  • Non-CNS Time to Progession in Cohort A [ Time Frame: 12 months ]
    To determine the rate of Non-CNS time to progression in Cohort A by assessing the median number of days in Cycle 1, Day 1 until non-CNS disease progression
  • CNS TTP in Cohort A [ Time Frame: 12 months ]
    To determine the rate of CNS TTPin Cohort A by assessing the median number of days in Cycle 1, Day 1 to disease progression
  • Median Progression-Free Survival in Cohort B [ Time Frame: 12 months ]
    To determine the median progression-free survival (PFS) in Cohort B by assessing the median number of days from Cycle 1, Day 1 until disease progression or death
  • Rate of CNS Non-Progression in Cohort B [ Time Frame: 12 months ]
    To determine the rate of CNS non-progression at 3 and 6 months Cohort B by assessing the percentage of subjects in Cohort A without CNS disease progression 3 and 6 months after Cycle 1, Day 1
  • Non-CNS Time to Progession in Cohort B [ Time Frame: 12 months ]
    To determine the rate of Non-CNS time to progression in Cohort B by assessing the median number of days in Cycle 1, Day 1 until non-CNS disease progression
  • CNS TTP in Cohort B [ Time Frame: 12 months ]
    To determine the rate of CNS TTP in Cohort B by assessing the median number of days in Cycle 1, Day 1 to disease progression
  • Median Overall Survival in Cohort A [ Time Frame: 12 months ]
    To determine the median overall survival (OS) in Cohort A by measuring the median number of days from Cycle 1, Day 1 until death
  • Median Overall Survival in Cohort B [ Time Frame: 12 months ]
    To determine the median OS in Cohort B by measuring the median number of days from Cycle 1, Day 1 until death
  • Clinical Activity of tesevatinib against LM using Standard Cytology [ Time Frame: 12 months ]
    Evaluate the activity of tesevatinib in subjects with NSCLC as measured by decreases in NSCLC cells in the CSF using standard cytology as assessed by the percent change in the number of NSCLC cells in the CSF for each patient in cohort B from screening to Cycle 1, Day 14, from Day 14 to Cycle 3, Day 1, and from screening to Cycle 3, Day 1 (Cohort B)
  • Clinical Activity of tesevatinib against LM using Improvement in MRI Findings [ Time Frame: 12 months ]
    Evaluate the activity of tesevatinib in subjects with NSCLC as measured by changes in MRI findings consistent with leptomeningeal metastases (absent or present) for each patient in Cohort B from Cycle 1, Day 1 to Cycle 3, Day 1 and from Cycle 1, Day 1 to Cycle 5 Day 1 (Cohort B)
  • Pharmacokinetics [ Time Frame: 12 months ]
    To evaluate the concentration of tesevatinib in CSF versus plasma (Cohort B)
Not Provided
Not Provided
 
Study of Tesevatinib in Subjects With Non-Small Cell Lung Cancer, EGFR Activating Mutation, Prior Treatment With a Tyrosine Kinase Inhibitor, and Brain Metastases or Leptomeningeal Metastases
A Phase 2, Multicenter Study of Tesevatinib in Subjects With Non-Small Cell Lung Cancer, EGFR Activating Mutation, Prior Treatment With a Tyrosine Kinase Inhibitor, and Brain Metastases or Leptomeningeal Metastases
A study to assess the activity of tesevatinib in subjects with NSCLC and activating EGFR mutations who have disease progression with Brain Metastases (BM) or Leptomeningeal Metastases (LM) or who heave either BM or LM at initial presentation.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Small Cell Lung Cancer
  • Leptomeningeal Metastases
  • Brain Metastases
Drug: Tesevatinib
Other Name: KD019, XL647
  • Experimental: Cohort A - Brain Metastases
    Tesevatinib will be orally administered with a dose of 300 mg once daily to subjects with NSCLC who have progressed with BM
    Intervention: Drug: Tesevatinib
  • Experimental: Cohort B - Leptomeningeal Metastases
    Tesevatinib will be orally administered with a dose of 300 mg once daily to subjects with NSCLC who have progressed with LM
    Intervention: Drug: Tesevatinib
  • Experimental: Cohort C - Brain Metastases at initial presentation
    Tesevatinib will be orally administered with a dose of 300 mg once daily to subjects with NSCLC with BM at initial presentation
    Intervention: Drug: Tesevatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
June 2017   (Final data collection date for primary outcome measure)

Cohort A

Inclusion Criteria:

  • History of NSCLC with EGFR mutation or an EGFR activating mutation that has had a clinical response to erlotinib, afatinib, or gefitinib in the patient being enrolled.
  • Occurrence or progression of BM while receiving either erlotinib or afatinib or gefitinib. Previous systemic treatment included erlotinib or afatinib or gefitinib for at least 14 days. Patients may have received osimertinib or rociletinib, or other agents inhibiting the T790M EGFR mutation, but only if they then receive at least 14 days of treatment with erlotinib, afatinib, or gefitinib and have CNS but not peripheral progression
  • At least one measurable BM by RECIST 1.1 criteria (≥ 10mm in longest diameter). Target lesions must not have received stereotactic radiotherapy (SRS). If subject had prior whole brain radiotherapy (WBRT), progression in any measurable BM lesion must have occurred at least 3 months after the end of WBRT. Subjects with asymptomatic brain metastases may be enrolled without prior radiation therapy to the brain. Subjects with minimally symptomatic brain metastases may be enrolled without prior radiation therapy to the brain if they do not require immediate surgical or radiation therapy in the opinion of the treating investigator and in the opinion of a radiation therapy or neurosurgical consultant
  • Subjects in Cohort A may have asymptomatic LM detected by MRI. (Subjects with symptoms or signs attributed to LM will be enrolled in Cohort B whether or not they have brain metastases)
  • No clinically significant progression outside of the CNS on most recent EGFR inhibitor therapy
  • ECOG Score ≤2
  • No history of another malignancy in the 5 years prior to study entry, except treated non-melanoma skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix or Stage 1 or 2 cancers of other sites that have been treated surgically and have not recurred
  • Adequate organ and bone marrow functions
  • Serum potassium and magnesium levels above the lower limit of normal
  • No coexisting medical problems of sufficient severity to limit compliance with the study
  • Willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study
  • Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test)

Exclusion Criteria:

  • First day of dosing with tesevatinib is less than 2 weeks from the last treatment of cytotoxic chemotherapy, biological therapy, or immunotherapy, and less than 6 weeks for nitrosoureas and mitomycin C. Surgical procedures must have been performed at least 2 weeks prior to the start of study treatment. Subjects must have recovered from the reversible effects of prior lung cancer treatments, including surgery and radiation therapy (excluding alopecia)
  • First day of dosing with tesevatinib is less than 4 weeks from the last radiotherapy of the brain or spinal cord/cauda equina
  • First day of dosing with tesevatinib is less than 2 weeks from treatment with another investigational agent
  • Treatment with erlotinib must be discontinued at least 3 days prior to first dose of tesevatinib and treatment with afatinib or other tyrosine kinase inhibitor must be discontinued at least 3 days prior to first dose of tesevatinib
  • Any concurrent therapy for BM other than the specified treatment in this study
  • Taking any medication known to moderately or severely inhibit the CYP3A4 isozyme or any drugs that are CYP3A4 inducers (including anti-epileptic agents such as phenytoin). A stable regimen (≥ 4 weeks) of antidepressants of the SSRI class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and fluoxetine)
  • Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
  • Has evidence of active heart disease such as myocardial infarction within the 3 months prior to study entry; symptomatic coronary insufficiency congestive heart failure; moderate or severe pulmonary dysfunction
  • History of torsades de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 50 bpm), heart block (excluding first degree block, being PR interval only), or congenital long QT syndrome. Subjects with a history of atrial arrhythmias should be discussed with the medical monitor
  • Has an active infectious process
  • Female subject who is pregnant or lactating
  • Known contraindication to MRI, such as cardiac pacemaker, shrapnel, or ocular foreign body
  • Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval > 470 msec) using the Fridericia method of correction for heart rate
  • Gastrointestinal (GI) condition that interferes with drug absorption
  • Non-malignant neurological disease that would interfere with evaluation of symptoms or signs of brain metastases

Cohort B

Inclusion Criteria:

  • History of NSCLC with EGFR mutation (either exon 19 deletion or L858R mutation) or, if previously treated, history of an activating EGFR mutation that has had a clinical response to erlotinib, afatinib, or gefitinib in the patient being enrolled).
  • Presentation with LM at initial presentation with no prior systemic treatment, or occurrence or progression of LM while receiving either erlotinib or afatinib or gefitinib. Previous systemic treatment included erlotinib or afatinib or gefitinib for at least 14 days. Patients may have received osimertinib or rociletinib, or other agents inhibiting the T790M EGFR mutation, but only if they then receive at least 14 days of treatment with erlotinib, afatinib, or gefitinib and have CNS but not peripheral progression
  • Presence of at least one CTCAE 4.03 symptom/sign of at least Grade 1 attributed by the investigator to leptomeningeal metastases
  • Diagnosis of LM by:

    1. Cytological evidence in CSF sample of LM due to NSCLC, and/or
    2. Findings on gadolinium-enhanced MRI
  • No clinically significant progression outside of the CNS on most recent EGFR inhibitor therapy
  • Concomitant brain metastases and brain metastases previously treated with radiation therapy are allowed. (Subjects with symptoms or signs attributed to LM will be enrolled in Cohort B whether or not they have brain metastases)
  • ECOG Score ≤2
  • No history of another malignancy in the 5 years prior to study entry, except treated non-melanoma skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix or Stage 1 or 2 cancers of other sites that have been treated surgically and have not recurred.
  • Adequate organ and bone marrow functions
  • Serum potassium and magnesium levels above the lower limit of normal
  • No coexisting medical problems of sufficient severity to limit compliance with the study
  • Willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study
  • Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test)

Exclusion Criteria:

  • First day of dosing with tesevatinib is less than 2 weeks from the last treatment of cytotoxic chemotherapy, biological therapy, or immunotherapy, and less than 6 weeks for nitrosoureas and mitomycin C. Surgical procedures must have been performed at least 2 weeks prior to the start of study treatment. Subjects must have recovered from the reversible effects of prior lung cancer treatments, including surgery and radiation therapy (excluding alopecia)
  • First day of dosing with tesevatinib is less than 4 weeks from the last radiotherapy of the brain or spinal cord/cauda equina
  • First day of dosing with tesevatinib is less than 2 weeks from treatment with another investigational agent
  • Treatment with erlotinib must be discontinued at least 3 days prior to first dose of tesevatinib and treatment with afatinib or other tyrosine kinase inhibitor must be discontinued at least 3 days prior to first dose of tesevatinib
  • Any concurrent therapy for LM other than the specified treatment in this study
  • Taking any medication known to moderately or severely inhibit the CYP3A4 isozyme or any drugs that are CYP3A4 inducers (including anti-epileptic agents such as phenytoin). A stable regimen (≥ 4 weeks) of antidepressants of the SSRI class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and fluoxetine)
  • Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
  • Has evidence of active heart disease such as myocardial infarction within the 3 months prior to study entry; symptomatic coronary insufficiency congestive heart failure; moderate or severe pulmonary dysfunction
  • History of torsades de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 50 bpm), heart block (excluding first degree block, being PR interval only), or congenital long QT syndrome. Subjects with a history of atrial arrhythmias should be discussed with the medical monitor
  • Has an active infectious process
  • Female subject who is pregnant or lactating
  • Known contraindication to MRI, such as cardiac pacemaker, shrapnel, or ocular foreign body
  • Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval > 470 msec) using the Fridericia method of correction for heart rate
  • Gastrointestinal (GI) condition that interferes with drug absorption
  • Non-malignant neurological disease that would interfere with evaluation of symptoms or signs of leptomeningeal metastases
  • Contraindications to lumbar puncture:

    1. INR > 1.5
    2. Platelets < 50 × 109/L (Note that platelets are required to be ≥100× 109/L at screening)
    3. Therapeutic anticoagulant treatment that can't be held for 24 hours. Low dose low molecular weight heparin given for deep vein thrombosis (DVT) prophylaxis is allowed.
    4. CNS lesions considered to be at risk for cerebral herniation, myelocompression, or conus/cauda compression

Cohort C

Inclusion Criteria:

  • NSCLC with EGFR activating mutation
  • No prior systemic treatment for NSCLC. Treatment with systemic steroids is not considered systemic treatment for NSCLC
  • No prior radiation therapy to the CNS (brain or spinal cord)
  • At least one measurable BM by RECIST 1.1 criteria (≥ 10mm in longest diameter) in a subject with asymptomatic or minimally symptomatic brain metastases who does not require immediate surgical or radiation therapy in the opinion of the treating investigator and in the opinion of a radiation therapy or neurosurgical consultant.
  • Subjects in Cohort C may have asymptomatic LM detected by MRI
  • ECOG Score ≤2
  • No history of another malignancy in the 5 years prior to study entry, except treated non-melanoma skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix or Stage 1 or 2 cancers of other sites that have been treated surgically and have not recurred
  • Adequate organ and bone marrow functions
  • Serum potassium and magnesium levels above the LLN
  • No coexisting medical problems of sufficient severity to limit compliance with the study.
  • Willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study
  • Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test)

Exclusion Criteria:

  • Surgical procedures that were performed less than 2 weeks prior to the start of study treatment
  • Any concurrent therapy for BM other than the specified treatment in this study
  • Taking any medication known to moderately or severely inhibit the CYP3A4 isozyme or any drugs that are CYP3A4 inducers (including anti-epileptic agents such as phenytoin). A stable regimen (≥ 4 weeks) of antidepressants of the SSRI class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and fluoxetine)
  • Taking any drugs associated with torsades de pointes or known to moderately or severely prolong the QTc(F) interval
  • Has evidence of active heart disease such as myocardial infarction within the 3 months prior to study entry; symptomatic coronary insufficiency congestive heart failure; moderate or severe pulmonary dysfunction
  • History of torsades de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 50 bpm), heart block (excluding first degree block, being PR interval only), or congenital long QT syndrome. Subjects with a history of atrial arrhythmias should be discussed with the medical monitor
  • Has an active infectious process
  • Female subject who is pregnant or lactating
  • Known contraindication to MRI, such as cardiac pacemaker, shrapnel, or ocular foreign body
  • Has marked prolongation of QTc(F) interval at screening or Cycle 1 Day 1 (QTc[F] interval > 470 msec) using the Fridericia method of correction for heart rate
  • GI condition that interferes with drug absorption
  • Non-malignant neurological disease that would interfere with evaluation of symptoms or signs of brain metastases
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
United States
 
 
NCT02616393
KD019-206
Yes
Not Provided
Not Provided
Kadmon Corporation, LLC
Kadmon Corporation, LLC
Not Provided
Not Provided
Kadmon Corporation, LLC
March 2017

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