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

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

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

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

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

3. Life expectancy of at least 3 months.

4. ECOG performance status of 0 to 2.

5. Ability to follow the study and all protocol requirements.

6. Voluntarily sign an informed consent form

7. 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.

8. Recovery to excluding alopecia.

Exclusion Criteria:

1. 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

2. 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).

3. 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.

4. Inadequate renal function - serum creatinine >1.5 x ULN.

5. Uncontrolled hypomagnesemia or hypokalemia, defined as ≥ Grade 3 despite adequate
electrolyte supplementation.

6. Baseline QTcF >450 msec in men or >470 msec in women.

7. Concurrent treatment with any agent known to prolong the QTc interval.

8. Prior surgery affecting drug absorption or any gastrointestinal dysfunction that
could alter drug absorption (e.g. gastric bypass, Whipple procedure, gastrectomy).

9. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
requiring medication or mechanical control within the last 6 months.

10. 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

- experiencing continued symptoms from venous thromboembolic event (e.g. continued
dyspnea or oxygen requirement) *Past venous thromboembolic event but do not meet
any of the above three criteria are eligible for participation.

11. History of a seizure within the last 10 years or seizure disorder requiring
anti-epileptic medications.

12. Concurrent treatment with medications known to lower the seizure threshold.

13. Concurrent administration of the medications or foods which are known to inhibit or
induce CYP3A activity to a clinically relevant degree.

14. Presence of active infection or systemic use of antibiotics within 72 hours of

15. 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.

16. Known immunodeficiency virus (HIV) positivity.

17. Pregnant or lactating women.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6mths to 1 year

Safety Issue:


Principal Investigator

Robert Ross, MD

Investigator Role:

Study Director

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

April 2012

Related Keywords:

  • Neoplasms
  • solid tumor malignancies
  • Neoplasms



Stanford University Stanford, California  94305
University of Colorado Health Science Center Aurora, Colorado  80010-0510
TGEN Clinical Research Service at Scottsdale Healthcare Scottsdale, Arizona  85258
Johns Hopkins Uninversity Baltimore, Maryland  21231