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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 belowSelect...
I am able to care for myself and perform daily activities.
Select...
My organ functions are within normal ranges according to recent tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ eot 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eot 1 year
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 2
~260
ruxolitinib
2017
Completed Phase 3
~600
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
214 Previous Clinical Trials
60,933 Total Patients Enrolled
Michael Savona, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center
4 Previous Clinical Trials
218 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a bone marrow biopsy within the last 4 weeks to check my fibrosis score.I am able to care for myself and perform daily activities.I have recovered from previous cancer treatment side effects, except for hair loss and certain blood conditions.My organ functions are within normal ranges according to recent tests.I haven't had any cancer except for skin, prostate, cervical, or DCIS in the last 2 years.I haven't had a stroke, heart attack, or severe heart rhythm problems in the last 6 months.I have had a recent stem cell transplant or have active graft-versus-host disease.I have not had recent major surgery, chemotherapy, or immunotherapy.I can follow the study's requirements without any issues.I have a confirmed diagnosis of a specific type of bone marrow disorder and am at an intermediate or high risk.I have a history of HIV or active hepatitis A, B, or C.I am currently on immunosuppressive therapy or have recently had radiotherapy.I have been diagnosed with MF, PV, CMML, aCML, RARS-T, or MDS/MPN-U and can get ruxolitinib.I have not taken any experimental drugs or specific inhibitors recently.I haven't taken specific drugs recently.
Research Study Groups:
This trial has the following groups:- Group 1: Escalation and expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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