Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers

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Brief Title

Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers

Official Title

A Phase II Study of Ponatinib in Cohorts of Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers

Brief Summary

      This phase II trial studies how well ponatinib hydrochloride works in treating patients with
      stage III-IV lung cancer. Ponatinib hydrochloride may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth.
    

Detailed Description

      This study will look at the safety and effectiveness of the investigational drug ponatinib in
      lung cancer. The investigators hope that ponatinib will work against tumors that have certain
      biomarkers. Therefore, the study will pre-screen patients for these certain biomarkers before
      enrolling them into the main treatment study. Different doses of ponatinib may be tested in
      this study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Prevalence of each biomarker (Part A)

Secondary Outcome

 Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

Condition

Adenocarcinoma of the Lung

Intervention

Ponatinib

Study Arms / Comparison Groups

 Ponatinib
Description:  Patients receive ponatinib hydrochloride taken by mouth once or twice a day. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

110

Start Date

May 21, 2014

Completion Date

December 2020

Primary Completion Date

January 2017

Eligibility Criteria

        Inclusion Criteria:

          -  PART A: Patients must have histologically or cytologically confirmed locally advanced
             (after failure of local therapy) or metastatic lung cancer (any histology, except
             carcinoid) stage IIIa, IIIb or IV

          -  PART A: Existing formalin fixed paraffin embedded biopsy of the lung cancer with
             potentially sufficient material for analysis

          -  PART A: Non-small cell lung cancer (NSCLC) with adenocarcinoma histology must have
             been previously tested for both epidermal growth factor receptor (EGFR) mutations and
             anaplastic lymphoma kinase (ALK) rearrangements

          -  PART A: Able (physically and financially) to travel to University of Colorado for
             clinical trial treatment

          -  PART B: Patients must have histologically or cytologically confirmed locally advanced
             (after failure of local therapy) or metastatic lung cancer (any histology, except
             carcinoid) stage IIIa, IIIb or IV

          -  PART B: Patients must be proven to meet marker criteria (FGFR1 silver in situ
             hybridization (SISH) + in situ hybridization (ISH) +, FGFR1 SISH+ ISH negative [-ve],
             FGFR1 SISH-ve ISH+, FGFR1 SISH-ve ISH-ve [FGFR1 double negative cohort] or ret
             proto-oncogene [RET] FISH+) prior to enrollment into Part B (treatment);
             adenocarcinoma patients must be known to not possess either an EGFR mutation or an ALK
             rearrangement in their tumor (if positive for one, testing for both is not required)

          -  PART B: Patients must have measurable disease as per Response Evaluation Criteria in
             Solid Tumors (RECIST) version 1.1

          -  PART B: Patients may have received any number of lines of prior therapy

          -  PART B: Life expectancy of >= 3 months

          -  PART B: Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky
             >= 60%)

          -  PART B: Leukocytes >= 3,000/mcL

          -  PART B: Absolute neutrophil count >= 1,500/mcL

          -  PART B: Hemoglobin >= 9 g/dL

          -  PART B: Platelets >= 100,000/mcL

          -  PART B: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), unless due
             to Gilbert's syndrome

          -  PART B: Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 X ULN

          -  PART B: Creatinine =< 1.5 X ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for
             patients with creatinine levels above institutional normal

          -  PART B: Serum lipase =< 1.5 X ULN

          -  PART B: Serum amylase =< 1.5 X ULN

          -  PART B: Previous treatment related side-effects/adverse events must have resolved to
             at least grade 1 or, at the discretion of the investigator, select stable grade 2
             toxicities (e.g. alopecia or fatigue) may be permissible if unchanging in grade for at
             least 3 months following discussion with the principal investigator (PI)

          -  PART B: Patients with central nervous system (CNS) metastases are eligible for
             enrollment if they have no overt evidence of neurological deficits, and are not
             requiring anti-epileptics or steroids to control their neurological symptoms; patients
             with known CNS metastases must have relevant CNS imaging performed approximately
             coincident with body imaging during response assessments

          -  PART B: The effects of ponatinib on the developing human fetus are unknown; for this
             reason women of child-bearing potential must have a negative urine or blood pregnancy
             test at screening for Part B; women of child-bearing potential and men must also have
             documented agreement to use adequate contraception (hormonal or barrier method of
             birth control; abstinence) from the time of screening until 30 days after the end of
             study treatment; should a woman become pregnant or suspect she is pregnant while she
             or her partner are participating in this study, they should inform the treating
             physician immediately

          -  PART B: Ability to understand and the willingness to sign a written informed consent
             document

        Exclusion Criteria:

          -  PART A: Known EGFR mutation and/or ALK rearrangement in NSCLC with adenocarcinoma
             histology

          -  PART B: No previous treatment with a standard or investigational anti-cancer agent
             within predicted 5 half-lives of the agent; or 28 days whichever is the shorter; if
             the plasma half-life is not known or the previous therapy was a monoclonal antibody
             then a 28 day washout period will be considered as the default requirement

          -  PART B: No previous or current exposure to other FGFR inhibitors in the FGFR-selected
             cohorts, or RET inhibitors in the RET selected cohorts

          -  PART B: Prior radiotherapy to proposed target lesions is not permitted unless
             completed more than 4 weeks prior to treatment within the study and that there has
             been documented progression at these sites; radiotherapy to non-target lesions is
             permitted within 2 weeks of study entry provided all acute effects of the radiotherapy
             have resolved to =< grade 1

          -  PART B: History of allergic or severe reactions attributed to compounds of similar
             chemical or biologic composition to ponatinib

          -  PART B: Ponatinib is a substrate for cytochrome P450, family 3, subfamily A,
             polypeptide 4/5 (CYP3A4/5), concurrent use with potent CYP3A4/5 inhibitors or inducers
             should be undertaken with caution

          -  PART B: History of clinically significant bleeding disorder

          -  PART B: History of acute pancreatitis within 1 year of study or history of chronic
             pancreatitis

          -  PART B: Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)

          -  PART B: Uncontrolled intercurrent illness including, but not limited to:

               -  Ongoing or active infection requiring intravenous antibiotics

               -  Psychiatric illness/social situations that would limit compliance with study
                  requirements

               -  Congestive heart failure, unstable angina pectoris, or myocardial infarction
                  within the 3 months prior to enrollment in part B of the study

               -  History of clinically significant (as determined by the treating medical doctor
                  [MD]) cardiac arrhythmia (atrial or ventricular)

          -  PART B: Patients who have had major surgery within 28 days prior to entering the study
             or those who have not recovered from adverse events > grade 1 relating to the surgery

          -  PART B: Pregnant or breastfeeding women

          -  PART B: Patients with inability to take oral medications, or, in the investigator's
             opinion, gastrointestinal conditions or abnormalities likely to influence the
             absorption of oral medications

          -  PART B: Concomitant use of medications known to be associated with torsades-de-pointes
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ross D Camidge, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01935336

Organization ID

13-2002.cc

Secondary IDs

NCI-2013-01644

Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver

Collaborators

 Ariad Pharmaceuticals

Study Sponsor

Ross D Camidge, MD, PhD, Principal Investigator, University of Colorado, Denver


Verification Date

November 2019