Study Evaluating IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) Following Failure of at Least Imatinib and Sunitinib
Status and phase
Conditions
Treatments
Details and patient eligibility
About
IPI-504-06 is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of IPI-504 as compared to placebo in patients with metastatic and/or unresectable GIST following failure of at least imatinib and sunitinib.
Approximately 195 patients will be randomized using a 2:1 ratio to receive either IPI-504 (N=130) or placebo (N=65). Upon unblinding, patients receiving either IPI-504 or placebo may receive IPI-504 in the open-label portion of the study if defined inclusion criteria are met.
Early and frequent imaging timepoints (Weeks 2, 5, 8, 14 and every 6 weeks thereafter) are incorporated into this study to capture progression events and limit patient exposure to ineffective agents.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- At least 18 years of age at the time of study randomization.
- Histologically confirmed metastatic and/or unresectable GIST.
- Measurable disease on CT or MRI as defined by RECIST.
- Documented radiographic progression or intolerance to imatinib and sunitinib.
- Clinical failure of the most recent prior therapy for GIST. Note: There is no limit to the number of prior therapies a patient may have received.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
- Hemoglobin ≥ 8.0 g/dL (80 g/L).
- Absolute Neutrophil Count ≥ 1500/µL (1.5 x 109/L).
- Platelets ≥ 100,000 /µL (100 x 109/L).
- ALT and AST ≤ 2.5 x upper limit of normal (ULN), or ≤ 5.0 x ULN if considered secondary to liver metastases.
- Alkaline phosphatase ≤ 2.5 x ULN, or ≤ 5.0 x ULN if considered secondary to liver metastases.
- Serum bilirubin ≤ 1.5 x ULN.
- PT and PTT ≤ 1.5 x ULN unless the patient is receiving warfarin. If the patient is receiving warfarin, the INR must be within therapeutic range.
- Serum creatinine ≤ 1.5 x ULN.
Exclusion criteria
- Previous administration of other known heat shock protein 90 (Hsp90) inhibitors.
- Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease.
- Initiation or discontinuation of concurrent medication that is a potent CYP3A inhibitor less than 2 weeks prior to administration of IPI-504 or placebo.
- History of any of the following within the last 6 months: cardiac disease such as acute coronary syndrome or unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, cirrhotic liver disease, cerebrovascular accident, or any other 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.
- Grade 3 or 4 hemorrhagic event within the last 6 months.
- Known human immunodeficiency virus positivity.
- Sinus bradycardia (resting heart rate < 50 bpm) secondary to intrinsic conduction system disease.
- QTcF ≥ 470 milliseconds, or previous history of clinically significant QTc prolongation while taking other medications.
- History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled, prostate cancer that has been treated and has not recurred, non-muscle-invasive bladder cancer, and carcinoma in situ of the cervix.
- Active or recent history (within 3 months) of keratitis or keratoconjunctivitis confirmed by ophthalmology or optometry exam.
- Presence of Left Bundle Branch Block, Right Bundle Branch Block plus left anterior hemiblock, bifascicular block, or 3rd degree heart block. This does not include patients with a history of these events with adequate control by pacemaker.
- Known CNS metastases.
- Women who are pregnant or lactating.
Trial design
Primary purpose
Allocation
Interventional model
Masking
47 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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