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A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Highlands Oncology Group/Research
Fayetteville, Arkansas, 72703 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC
(Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and
Drug Administration (FDA) approved FISH assay (Abbott Molecular Inc) or by
Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by
FISH or RT PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT).
All patients (ALK positive and ROS1 positive) must have archival tissue sample
available and collected prior to enrollment.

- Disease Status Requirements:

Phase 1: ALK-positive NSCLC and ROS1-positive patients must either be treatment naïve in
the advanced setting or have had disease progression after at least 1 previous ALK/ROS1
inhibitor therapy(ies).

Phase 2:

ALK-positive NSCLC patients must either be or have had:

- Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no
prior ALK inhibitor therapy allowed).

- Disease progression after crizotinib only. No prior chemotherapy is allowed in the
metastatic disease setting.

- Disease progression after crizotinib and 1 or 2 prior regimens of chemotherapy in the
metastatic disease setting.

- Disease progression after 1 prior ALK inhibitor therapy other than crizotinib.
Patients may have had any number of prior chemotherapy regimens in any disease
setting.

- Disease progression after 2 prior ALK inhibitor therapies. Patients may have had any
number of prior chemotherapy regimens in any disease setting.

- Disease progression after 3 prior ALK inhibitor therapies. Patients may have had any
number of prior chemotherapy regimens in any disease setting.

ROS1-positive NSCLC patients may be:

- Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no
prior ROS inhibitor therapy).

- Any number of prior therapies (ie, chemotherapy and/or ROS inhibitor therapies).

- Tumor Requirements:

All Patients must have at least one measurable target extracranial lesion according to
RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients
asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks
prior to study entry) will be eligible. Patients who have leptomeningeal disease (LM) or
carcinomatous meningitis (CM) are eligible.

- Adequate Bone Marrow, Pancreatic Function, Renal Function and Liver Function.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study
entry. Whole brain radiation must have completed at least 4 weeks prior to study
entry.

- Systemic anti cancer therapy completed within a minimum of 5 half lives of study
entry.

- Prior therapy with an antibody or drug specifically targeting T-cell co-stimulation or
immune checkpoint pathways, including, but not limited to, anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4
(anti-CTLA-4) antibody.

- Active and clinically significant bacterial, fungal, or viral infection including
hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or
acquired immunodeficiency syndrome (AIDS) related illness.

- Clinically significant cardiovascular disease (that is, active or enrollment): cerebral vascular accident/stroke, myocardial infarction, unstable
angina, congestive heart failure (New York Heart Association Classification Class ?
II), second-degree or third-degree AV block (unless paced) or any AV block with PR
>220 msec. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ?2, uncontrolled atrial
fibrillation of any grade, bradycardia defined as healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or
congenital long QT syndrome.

- History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial
fibrosis or interstitial lung disease including a history of pneumonitis,
hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease,
obliterative bronchiolitis and pulmonary fibrosis.

- Current use or anticipated need for food or drugs that are known strong or moderate
CYP3A4 inhibitors, inducers and substrates; drugs that are CYP2C9 substrates; drugs
that are sensitive CYP2B6 substrates; drugs that are strong CYP2C19 inhibitors; drugs
that are strong CYP2C8 inhibitors; and drugs that are P-gp substrates.

NCT01970865
Pfizer
Active, not recruiting
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

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Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
  • Drug: PF-06463922
    Oral, starting dose 10mg once a day, dose escalation in Phase 1 until recommended Phase 2 dose determined, continuous daily dosing, cycles lasting 21 days
  • Drug: Crizotinib
    Oral, starting dose of 250 mg BID continuous daily dosing every 21 days
    Other Name: Xalkori
  • Experimental: PF-06463922
    Intervention: Drug: PF-06463922
  • Crizotinib
    ALK+ NSCLC patients who are treatment naïve may be eligible to receive crizotinib following PF-06463922 as a substudy to the main study.
    Intervention: Drug: Crizotinib
Shaw AT, Friboulet L, Leshchiner I, Gainor JF, Bergqvist S, Brooun A, Burke BJ, Deng YL, Liu W, Dardaei L, Frias RL, Schultz KR, Logan J, James LP, Smeal T, Timofeevski S, Katayama R, Iafrate AJ, Le L, McTigue M, Getz G, Johnson TW, Engelman JA. Resensitization to Crizotinib by the Lorlatinib ALK Resistance Mutation L1198F. N Engl J Med. 2016 Jan 7;374(1):54-61. doi: 10.1056/NEJMoa1508887. Epub 2015 Dec 23.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
363
February 19, 2019
March 15, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA) approved FISH assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by FISH or RT PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT). All patients (ALK positive and ROS1 positive) must have archival tissue sample available and collected prior to enrollment.
  • Disease Status Requirements:

Phase 1: ALK-positive NSCLC and ROS1-positive patients must either be treatment naïve in the advanced setting or have had disease progression after at least 1 previous ALK/ROS1 inhibitor therapy(ies).

Phase 2:

ALK-positive NSCLC patients must either be or have had:

  • Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ALK inhibitor therapy allowed).
  • Disease progression after crizotinib only. No prior chemotherapy is allowed in the metastatic disease setting.
  • Disease progression after crizotinib and 1 or 2 prior regimens of chemotherapy in the metastatic disease setting.
  • Disease progression after 1 prior ALK inhibitor therapy other than crizotinib. Patients may have had any number of prior chemotherapy regimens in any disease setting.
  • Disease progression after 2 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.
  • Disease progression after 3 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.

ROS1-positive NSCLC patients may be:

  • Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ROS inhibitor therapy).
  • Any number of prior therapies (ie, chemotherapy and/or ROS inhibitor therapies).

    • Tumor Requirements:

All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. Patients who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) are eligible.

  • Adequate Bone Marrow, Pancreatic Function, Renal Function and Liver Function.
  • Negative Serum pregnancy test for females of childbearing potential Exclusion Criteria
  • Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry.
  • Systemic anti cancer therapy completed within a minimum of 5 half lives of study entry.
  • Prior therapy with an antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including, but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (anti-CTLA-4) antibody.
  • Active and clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
  • Clinically significant cardiovascular disease (that is, active or <3 months prior to enrollment): cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Classification Class ? II), second-degree or third-degree AV block (unless paced) or any AV block with PR >220 msec. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ?2, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or congenital long QT syndrome.
  • History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis.
  • Current use or anticipated need for food or drugs that are known strong or moderate CYP3A4 inhibitors, inducers and substrates; drugs that are CYP2C9 substrates; drugs that are sensitive CYP2B6 substrates; drugs that are strong CYP2C19 inhibitors; drugs that are strong CYP2C8 inhibitors; and drugs that are P-gp substrates.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Singapore,   Spain,   Switzerland,   Taiwan,   United States
 
 
NCT01970865
B7461001
2013-002620-17 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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