Summary

for people ages 18 years and up (full criteria)
at UC Irvine
study started
estimated completion:

Description

Summary

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 .

Official Title

Phase 1/2 Study Of Pf-06463922 (an Alk/ros1 Tyrosine Kinase Inhibitor) In Patients With Advanced Non-small Cell Lung Cancer Harboring Specific Molecular Alterations

Keywords

ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC Phase 1 Phase 2 safety pharmacokinetic pharmacodynamic efficacy Lung Neoplasms Carcinoma, Non-Small-Cell Lung Crizotinib PF-06463922

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • UC Irvine Medical Center
    Orange California 92868-3201 United States
  • Chao Family Comprehensive Cancer Center
    Orange California 92868-3201 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT01970865
Phase
Phase 2
Study Type
Interventional
Last Updated