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A Phase 2 Study With IPI-926 in Patients With Myelofibrosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase 2 Study With IPI-926 in Patients With Myelofibrosis

A Phase 2 Study of IPI-926 in Patients With Myelofibrosis

NCT01371617•Infinity Pharmaceuticals, Inc.

Summary

The purpose of this study is to determine the safety and efficacy of IPI-926 in patients with myelofibrosis (MF) (primary myelofibrosis \[PMF\], post-polycythemia vera myelofibrosis \[post-PV MF\], or post-essential thrombocythemia myelofibrosis \[post-ET MF\]).

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•≥18 years of age at the time of signing the ICF.
•Voluntarily sign an ICF.
•Pathologically confirmed PMF or post ET/PV MF as per the WHO diagnostic criteria (note that it must include at least Grade 1 marrow fibrosis, see Appendix 3) with intermediate-1, intermediate -2, or high risk disease according to the IWG prognostic scoring system (see Appendix 4). If patients have low risk disease, then they must have symptomatic splenomegaly that is ≥ 10 cm below left costal margin by physical exam.
•ECOG performance of 0-2.
•Life expectancy of at least 3 months.
•Recovery to Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia.
•If a woman, be of non-child bearing potential or, for women of child-bearing potential (WCBP) (defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months for women ≤55 years; for women \>55 years 12 consecutive months), must have a negative serum or urine pregnancy test result within 2 weeks of first dose of study drug.
•All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, and total abstinence.
•Ability to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria

•Prior treatment with any inhibitor of the hedgehog pathway (e.g. GDC-0449).
•Received any treatment for myelofibrosis within 2 weeks of study entry.
•Other invasive malignancies diagnosed within the last 3 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
•Inadequate hepatic function defined by:
•Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN).
•Direct bilirubin \>1.5 x ULN.
•Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis.
•Inadequate renal function defined by serum creatinine \>2 x ULN.
•History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
•Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
+4 more criteria

Locations (3)

Arizona Mayo Clinic

Scottsdale, Arizona, United States

Stanford University School of Medicine, Division of Hematology

Palo Alto, California, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

October 1, 2011

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

November 15, 2012

Enrollment

ACTUAL participants

Conditions

Primary MyelofibrosisFibrosis, Bone Marrow

Interventions

IPI-926

DRUG

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

NCT06343805

Primary MyelofibrosisPost-Essential Thrombocythemia Myelofibrosis+4 more

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ACTIVE_NOT_RECRUITINGPHASE1

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

NCT04279847

MyelofibrosisMyelodysplastic Syndrome+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 2 Study With IPI-926 in Patients With Myelofibrosis

Inclusion Criteria

Exclusion Criteria

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

Managed Access Programs for INC424, Ruxolitinib

A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies