A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies
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 = Grade 1 or baseline of any toxicities due to prior treatments,
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
- 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
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
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.