Phase 2
Completed N=122
Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
Lung Adenocarcinoma · Extensive-Stage Small-Cell Lung Cancer · limited-stage small cell lung cancer · Recurrent Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01935336 ↗
Enrolled (actual)
122
Serious AEs
75.0%
Results posted
Feb 2022
Primary outcomePrimary: Biomarker FGFR1 (ISH/SISH) Score (Part A) — 0.93; 0.07; 0.579; 0.42 gene copy number
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biomarker FGFR1 (ISH/SISH) Score (Part A) |
0.93; 0.07; 0.579; 0.42; 0.77; 0.23 | — |
| PRIMARY Overlapping Frequency of FGFR1 (ISH/SISH) Biomarkers (Part A) |
0.049; 0.0246; 0.385; 0.541 | — |
| PRIMARY Objective Response Rate (ORR) Per RECIST v1.1 (Part B) |
0; 0; 0; 0 | — |
| SECONDARY Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 |
0; 2; 1; 2 | — |
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 = = 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 = = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- PART B: Serum lipase = 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
Data sourced from ClinicalTrials.gov (NCT01935336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.