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JAK1/2 inhibitor

TGR-1202 + Ruxolitinib for Polycythemia Vera

Phase 1
Waitlist Available
Led By Michael Savona, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Must have adequate organ function as demonstrated by specific laboratory values
Timeline
Screening 3 weeks
Treatment Varies
Follow Up eot 1 year
Awards & highlights

Study Summary

This trial is testing a new drug to treat myeloproliferative neoplasms (a type of blood cancer) when used with another existing drug.

Who is the study for?
This trial is for adults with certain blood disorders (polycythemia vera, primary myelofibrosis, or MDS/MPN) who have not responded well to standard treatments like hydroxyurea or are newly diagnosed. Participants must be in stable health as indicated by specific blood and organ function tests and willing to use effective birth control.Check my eligibility
What is being tested?
The study is testing the combination of TGR-1202, a PI3K delta inhibitor, with ruxolitinib in patients with myeloproliferative neoplasms. It's an early-phase trial designed to evaluate safety and how well these drugs work together.See study design
What are the potential side effects?
Potential side effects may include changes in liver enzymes, bilirubin levels indicating liver function issues, kidney function alterations measured by creatinine levels, as well as general symptoms such as fatigue. Specific side effects related to TGR-1202 or ruxolitinib will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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My organ functions are within normal ranges according to recent tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eot 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and eot 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of TGR1202 in combination with ruxolitinib
Secondary outcome measures
Blood levels of TGR1202 in combination with ruxolitinib (Pharmacokinetics)
Overall response
Total symptom score (MPN-TSS)
Other outcome measures
JAK2V617F allele burden
Mutations found on next generation sequencing (NGS) correlated with response
TGR-1202's effects plasma cytokine levels when added to ruxolitinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Escalation and expansionExperimental Treatment2 Interventions
TGR1202 and Ruxolitinib combination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TGR-1202
2015
Completed Phase 3
~810
ruxolitinib
2017
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,873 Total Patients Enrolled
Michael Savona, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center
4 Previous Clinical Trials
218 Total Patients Enrolled

Media Library

ruxolitinib (JAK1/2 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02493530 — Phase 1
Polycythemia Vera Research Study Groups: Escalation and expansion
Polycythemia Vera Clinical Trial 2023: ruxolitinib Highlights & Side Effects. Trial Name: NCT02493530 — Phase 1
ruxolitinib (JAK1/2 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02493530 — Phase 1

Frequently Asked Questions

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

Are there various sites executing this research in the US and Canada?

"Presently, this clinical trial is available at 5 distinct sites located in Nashville, Aurora and Phoenix among others. To mitigate the travel burden associated with enrollment, it may be best to select a site that is closest to you."

Answered by AI

Could you elucidate the potential risks associated with TGR-1202?

"With limited data to suggest both safety and efficacy, TGR-1202 was given an assessment of 1."

Answered by AI

In what conditions has TGR-1202 demonstrated efficacy?

"TGR-1202 has been proven to help patients manage lymphoma, polycythemia vera, and polycythemia."

Answered by AI

Are there any openings remaining for participants in this research?

"This medical trial has concluded its recruitment process, having last been updated on June 20th 2022. However, there are presently 153 clinical trials recruiting patients with polycythemia vera and 108 trails looking for participants receiving TGR-1202 treatments."

Answered by AI

What is the upper limit of participants for this research endeavor?

"This research project is not presently accepting participants. Although the trial was initially posted in July 2015, it has since been updated as of June 2022. For those seeking alternative studies, 153 trials for polycythemia vera and 108 studies concerning TGR-1202 are currently recruiting patients."

Answered by AI

Are there any existing reports associated with TGR-1202?

"TGR-1202 was first investigated at the NIH Clinical Center in 2002 and since then 100 trials have been completed. At present, there are 108 active experiments taking place across multiple locations with a concentration of research occurring in Nashville, Tennessee."

Answered by AI
~6 spots leftby Apr 2025