18 and older, any sex, with Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response, Defined as the Number of Patients Who Achieve Any Response According to Disease Type in the First 6 Courses of TreatmentPrimary· Up to 6 months
The proportion of responses for the purposes of the decision rule will be calculated out of all eligible patients who receive any treatment. Assuming the number of responses is binomially distributed, 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses. Response for tumors was assessed using the RECIST 1.1 criteria (using computed tomography \[CT\] scans), where response was defined as a partial or complete response.
Group
Value
95% CI
Participants With Genomic Alterations in FGFR
1
Participants With Genomic Alterations in Rare Genomic Targets (KIT, PDGFRα, RET, ABL1, and FLT3)
0
Percentage of Participants With Adverse Events, Defined as Adverse Events That Are Classified as Either Possibly, Probably, or Definitely Related to Study Treatment Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Secondary· Up to 30 days after last dose of study drug, up to a total of 6 years
Frequency and severity of adverse events will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns for each of the cohorts as well as across cohorts. In addition, all adverse event data that is graded as 3, 4, or 5 will be reviewed and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing.
Dry Skin, Grade 1
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
36.4
Dry Skin, Grade 2
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
4.6
Dry Skin, Grade ≥3
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
9.1
Rash Maculo-papular, Grade 1
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
27.3
Rash Maculo-papular, Grade 2
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
9.1
Hypertension, Grade 1
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
4.6
Hypertension, Grade 2
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
9.1
Hypertension, Grade ≥3
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
13.6
Tolerability of the Regimen, Assessed by the Number of Patients Who Required Dose Modifications and/or Dose DelaysSecondary· Up to 30 days after last dose of study drug
Collected and summarized by descriptive statistics.
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
11
Overall SurvivalSecondary· The time from treatment initiation to death, assessed up to 72 months
Kaplan-Meier curves will be used to estimate the survival distribution.
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
5.3
0 – 72
Progression Free SurvivalSecondary· The time from treatment initiation to progression or death, assessed up to 2 years
Kaplan-Meier curves will be used to estimate the survival distribution.
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
1.9
0 – 19.7
Clinical Benefit Rate (CBR)Secondary· 6 months
Calculated by the number of patients who have achieve a response and/or are progression-free and alive at 6 months divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for CBR will be calculated.
Group
Value
95% CI
Treatment (Ponatinib Hydrochloride)
31.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected for each patient from the start of treatment with the investigational drug up to 30 days after ending treatment. The total time period in which adverse event data was collected for this study was 6 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well ponatinib hydrochloride works in treating patients with cancer that has spread to other parts of the body (metastatic), has failed previous treatment (refractory), and has one of several alterations, or mutations, in its deoxyribonucleic acid (DNA) sequence. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether a patient's genetic alterations may affect how well ponatinib hydrochloride works.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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· Phase 1
· recruiting
NCT07131007 — Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics
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Other Sameek Roychowdhury trials
Trials by the same sponsor.
NCT06906562 — A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metasta
· Phase 2
· recruiting
NCT04233567 — Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
· Phase 2
· completed
NCT03868423 — Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers
· Phase 2
· withdrawn
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sameek Roychowdhury
Last refreshed: 24 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02272998.