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Tyrosine Kinase Inhibitor

Ponatinib for Cancer

Phase 2

Waitlist Available

Led By Sameek Roychowdhury, MD, PhD

Research Sponsored by Sameek Roychowdhury

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years (time of progression)

Awards & highlights

Study Summary

This trial looks at the effectiveness of ponatinib hydrochloride for treating metastatic cancer that has failed previous treatment and has DNA sequence alterations.

Eligible Conditions

Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years (time of progression)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years (time of progression)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years (time of progression) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response, defined as the number of patients who achieve any response according to disease type in the first 6 courses of treatment

Secondary outcome measures

Clinical benefit rate (CBR)

Incidence of toxicity, 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 4.0

Overall survival

+2 more

Other outcome measures

Correlative gene and protein markers

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ponatinib hydrochloride)Experimental Treatment2 Interventions

Patients receive ponatinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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Who is running the clinical trial?

Sameek RoychowdhuryLead Sponsor

2 Previous Clinical Trials

17 Total Patients Enrolled

Sameek Roychowdhury, MD, PhDPrincipal Investigator - Ohio State University Comprehensive Cancer Center

Ohio State University Comprehensive Cancer Center

1 Previous Clinical Trials

1,000 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical conditions is ponatinib hydrochloride typically prescribed?

"Ponatinib hydrochloride may be a useful treatment for renal dysfunction, leukemia, myeloid issues, accelerated phase ailments and chronic kidney disease."

Answered by AI

Has the FDA sanctioned ponatinib hydrochloride?

"Ponatinib hydrochloride has been rated a 2 for safety due to existing clinical evidence affirming its security, yet no data is available that can confirm the drug's efficacy."

Answered by AI

Is this experiment still open to new participants?

"To the contrary, clinicaltrials.gov indicates that this trial is not currently admitting participants; although initially published on February 24th 2015 and most recently updated on September 14th 2023, it does not appear to be in search of fresh patients presently. 2534 other trials are recruiting now though."

Answered by AI

Is this the premiere clinical trial in its field?

"Since 2007, ponatinib hydrochloride has been the subject of several medical investigations. The first trial was conducted in 2007 under Baxter Healthcare Corporations' sponsorship and involved 4640 patients. After that initial study, it received its Phase 4 drug approval before later being trialed across 1214 cities within 39 countries with 69 active trials ongoing."

Answered by AI

To what capacity is enrollment for this clinical trial currently open?

"This research protocol is no longer recruiting participants. Initially posted on February 24th 2015 and last revised in September 14th 2023; for those interested in alternative studies, there are presently 2465 trials with cancer-related objectives and 69 investigations involving ponatinib hydrochloride that are actively seeking patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT.

Sameek Roychowdhury 2015. "Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02272998.