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Primary MyelofibrosisPhase 2NCT01371617

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

A Phase 2 study testing IPI-926 in people with Primary Myelofibrosis and Fibrosis, Bone Marrow, run by Infinity Pharmaceuticals, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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]). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Primary Myelofibrosis, Fibrosis, Bone Marrow
What is being tested?
IPI-926
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
Oct 2011to Aug 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Significant co-morbid condition or disease, which in the judgment of the Investigator, would place the patient at undue risk or interfere with the study.
  • Known human immunodeficiency virus (HIV) positivity.
  • Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 capsules.
  • Pregnant or lactating women.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Stanford University School of Medicine, Division of Hematology

    Palo Alto, California, 94025

  • Arizona Mayo Clinic

    Scottsdale, Arizona, 85260

Other trials in United States

About this study

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

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]).

Being tested
IPI-926
Keywords
IPI-926, 926, Myelofibrosis, Hedgehog, Infinity Pharmaceuticals, Post Essential thrombocythemia, Post Polycythemia vera
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPI-926Drug

    Also called Hedgehog Inhibitor, Hedgehog Pathway Inhibitor

    Single Arm study of oral IPI-926 at 160 mg, 130 mg or 110 mg daily, until progressive disease or intolerability to study treatments or withdrawal of ICF

Study groups in NCT01371617
Study groupRoleWhat they receive
IPI-926ExperimentalSingle Arm, Phase 2 trial evaluating the safety and efficacy of IPI-926 in patients with myelofibrosis
Receives: Drug: IPI-926

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the overall response rate of IPI-926, defined as clinical improvement (CI); partial remission (PR); and complete remission (CR), according to the International working group (IWG) criteria in patients with Myelofibrosis

    Measured: At least 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01371617
Sponsor's protocol ID
IPI-926-08
Status last verified
Nov 2012
First submitted
9 Jun 2011
Last updated
15 Nov 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IPI-926 in people with Primary Myelofibrosis and Fibrosis, Bone Marrow, run by Infinity Pharmaceuticals, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the overall response rate of IPI-926, defined as clinical improvement (CI); partial remission (PR); and complete remission (CR), according to the International working group (IWG) criteria in patients with Myelofibrosis (time frame: At least 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01371617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2012.

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