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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
Must not have
Other invasive malignancies within the last 2 years, except non-melanoma skin cancer and localized cured prostate, cervical cancer, and DCIS
History of cerebral vascular accident, unstable angina, myocardial infarction, or ventricular arrhythmia within the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up </=12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, TGR-1202, combined with an existing drug, ruxolitinib, in patients with certain blood cancers who are not responding to current treatments. The goal is to see if blocking two different pathways can better stop cancer cell growth. Ruxolitinib is the first approved treatment for myelofibrosis and has shown efficacy in reducing spleen size and improving quality of life.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had any cancer except for skin, prostate, cervical, or DCIS in the last 2 years.
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I haven't had a stroke, heart attack, or severe heart rhythm problems in the last 6 months.
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I have had a recent stem cell transplant or have active graft-versus-host disease.
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I have not had recent major surgery, chemotherapy, or immunotherapy.
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I have a history of HIV or active hepatitis A, B, or C.
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I am currently on immunosuppressive therapy or have recently had radiotherapy.
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I have not taken any experimental drugs or specific inhibitors recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~</=12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and </=12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety of TGR1202 in combination with ruxolitinib
Secondary study objectives
Blood levels of TGR1202 in combination with ruxolitinib (Pharmacokinetics)
Overall response
Total symptom score (MPN-TSS)
Other study objectives
JAK2V617F allele burden

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 1
~270
ruxolitinib
2017
Completed Phase 3
~660

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Ruxolitinib, a JAK1/2 inhibitor, works by blocking the Janus kinase (JAK) pathway, which is often overactive in PV due to mutations like JAK2 V617F. This inhibition reduces the excessive production of blood cells, alleviating symptoms and reducing spleen size. TGR-1202, a PI3K delta inhibitor, targets the PI3K/AKT/mTOR pathway, which is involved in cell growth and survival. By inhibiting this pathway, TGR-1202 can help control abnormal cell proliferation. These mechanisms are crucial for PV patients as they address the underlying causes of the disease, helping to manage symptoms and prevent complications such as thrombosis and progression to myelofibrosis.

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
218 Previous Clinical Trials
64,296 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
~6 spots leftby Dec 2025