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A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies
This study is currently recruiting participants.
Verified by Infinity Pharmaceuticals, September 2008
Sponsored by: Infinity Pharmaceuticals
Information provided by: Infinity Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00761696
  Purpose

The primary objectives of the study are:

  • To determine the safety and the maximum tolerated dose (MTD) of IPI-926
  • To examine the pharmacokinetic parameters of IPI-926 and its characterized major metabolite(s)
  • To recommend a dose and schedule of IPI-926 for subsequent studies

Condition Intervention Phase
Neoplasms
Drug: IPI-926
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies

Further study details as provided by Infinity Pharmaceuticals:

Primary Outcome Measures:
  • To determine the safety and the maximum tolerated dose (MTD) of IPI-926 [ Time Frame: 6mths to 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the anti-tumor activity of IPI-926 [ Time Frame: 6mths to 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IPI-926: Experimental
Oral daily dosing
Drug: IPI-926
Oral daily dosing

Detailed Description:

Study IPI-926-01 is a Phase 1, open-label, dose-escalation study in patients with advanced and/or metastatic solid tumor malignancies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically confirmed diagnosis of a solid tumor for which no standard therapy proven to provide clinical benefit is available.
  2. ≥18 years of age at the time of signing the informed consent.
  3. Life expectancy of at least 3 months.
  4. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria:

  1. Inadequate hematologic function defined by absolute neutrophil count (ANC) <1,500 cells/mm3, platelet count <100,000/mm3, or hemoglobin <9.0 g/dL (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
  2. Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN); >5 x ULN if attributable to liver metastases; total bilirubin >1.5 x ULN.
  3. Inadequate renal function defined by serum creatinine >1.5 x ULN.
  4. Uncontrolled hypomagnesemia or hypokalemia, defined as ≥ Grade 3 despite adequate electrolyte supplementation.
  5. Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
  6. History of a seizure within the last 10 years or seizure disorder requiring anti-epileptic medications.
  7. History of brain metastases or primary brain tumor.
  8. 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.
  9. Pregnant or lactating women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761696

Locations
United States, Arizona
TGen Clinical Research Service at Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Karen Lewandowski, RN     480-323-1019     KLewandowski@SHC.org    
Principal Investigator: Glen Weiss, MD            
Sponsors and Collaborators
Infinity Pharmaceuticals
Investigators
Study Director: Robert Ross, MD Infinity Pharmaceuticals
  More Information

Responsible Party: Infinity Pharmaceuticals ( Alicia LeBlanc )
Study ID Numbers: IPI-926-01
Study First Received: September 25, 2008
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00761696  
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals:
solid tumor malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on January 14, 2009