A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies

NCT00761696 | Completed Phase 1

• 1 other identifier: IPI-926-01
• Study Type: interventional
• Target: 94
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

Neoplasms

Keywords

solid tumor malignancies

Outcome Measures

Primary Outcomes (1)

• To determine the safety and the maximum tolerated dose (MTD) of IPI-926

  6mths to 1 year

Secondary Outcomes (1)

• To evaluate the anti-tumor activity of IPI-926

  6mths to 1 year

Study Arms (1)

IPI-926

EXPERIMENTAL

Oral daily dosing

Drug: IPI-926

Interventions

IPI-926 DRUG

Oral daily dosing

Also known as: Hedgehog pathway inhibitor

IPI-926

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed diagnosis of a solid tumor for which no standard therapy proven to provide clinical benefit is available.
• ≥18 years of age
• Life expectancy of at least 3 months.
• ECOG performance status of 0 to 2.
• Ability to follow the study and all protocol requirements.
• Voluntarily sign an informed consent form
• Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation of who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study.
• Recovery to \</= Grade 1 or baseline of any toxicities due to prior treatments, excluding alopecia.

You may not qualify if:

• Treatment with following therapies as indicated:
• Any chemotherapy (other than nitrosoureas or mitomycin C), radiation therapy, surgery, hormonal therapy, or investigational therapy within 4 weeks of the start of IPI-926 administration. Patients with luteinizing hormone releasing hormone therapy.
• Any tyrosine kinase inhibitor (e.g. erlotinib, imatinib) within 2 weeks of the start of IPI-926 administration
• Nitrosoureas o or mitomycin C within 6 weeks of the start of IPI-926 administration.
• Inadequate hematologic function - 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).
• Inadequate hepatic function - 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.
• Inadequate renal function - serum creatinine \>1.5 x ULN.
• Uncontrolled hypomagnesemia or hypokalemia, defined as ≥ Grade 3 despite adequate electrolyte supplementation.
• Baseline QTcF \>450 msec in men or \>470 msec in women.
• Concurrent treatment with any agent known to prolong the QTc interval.
• Prior surgery affecting drug absorption or any gastrointestinal dysfunction that could alter drug absorption (e.g. gastric bypass, Whipple procedure, gastrectomy).
• History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
• Venous thromboembolic event (e.g. pulmonary embolism or deep vein thrombosis) requiring anticoagulation or who meet any of the following criteria are excluded:
• have been on a stable dose of anticoagulation for \<1 month
• have had a Grade 2, 3 or 4 hemorrhage in the last 30 days

Sponsors & Collaborators

• Infinity Pharmaceuticals, Inc.: lead

Study Sites (5)

TGen Clinical Research Service at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

University of Colorado Health Science Center

Aurora, Colorado, 80045, United States

Location

Johns Hopkins Uninversity

Baltimore, Maryland, 21231, United States

Location

McGill University Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

IPI-926

Study Officials

• Robert Ross, MD

  Infinity Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 29, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

CA (1); US (4)