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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01371617
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : November 15, 2012
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE June 9, 2011
First Posted Date  ICMJE June 13, 2011
Last Update Posted Date November 15, 2012
Study Start Date  ICMJE October 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study With IPI-926 in Patients With Myelofibrosis
Official Title  ICMJE A Phase 2 Study of IPI-926 in Patients With Myelofibrosis
Brief 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]).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Myelofibrosis
  • Fibrosis, Bone Marrow
Intervention  ICMJE Drug: IPI-926
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
Other Names:
  • Hedgehog Inhibitor
  • Hedgehog Pathway Inhibitor
Study Arms  ICMJE Experimental: IPI-926
Single Arm, Phase 2 trial evaluating the safety and efficacy of IPI-926 in patients with myelofibrosis
Intervention: Drug: IPI-926
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2012)
14
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
45
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01371617
Other Study ID Numbers  ICMJE IPI-926-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Infinity Pharmaceuticals, Inc.
Study Sponsor  ICMJE Infinity Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Srdan Verstovsek, M.D.; Ph.D M.D. Anderson Cancer Center
PRS Account Infinity Pharmaceuticals, Inc.
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP