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Also known as Hedgehog Inhibitor, Hedgehog Pathway Inhibitor, Hedgehog
IPI-926 · 4 trials · 5 indications
* To compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo. * Number of Incidence of reported adverse events and abnormal laboratory test results. To evaluate the safety of IPI-926 or placebo in patients with metastatic or locally advanced (unresectable) chondrosarcoma
To determine the safety profile, including maximum tolerated dose, of IPI-926 plus gemcitabine in patients with previously untreated metastatic pancreatic cancer.
* To compare the overall survival (OS) of patients with previously untreated metastatic pancreatic cancer treated with IPI-926 plus gemcitabine or placebo plus gemcitabine. * To evaluate the safety of IPI-926 plus gemcitabine or placebo plus gemcitabine.
| Arm | Type | Description |
|---|---|---|
| IPI-926 | EXPERIMENTAL | Single Arm, Phase 2 trial evaluating the safety and efficacy of IPI-926 in patients with myelofibrosis |
| Sugar Pill | PLACEBO_COMPARATOR | Placebo Arm, sugar pill |
| Arm 1 (Phase 2) | ACTIVE_COMPARATOR | IPI-926 in combination with gemcitabine |
| Arm 2 (Phase 2) | PLACEBO_COMPARATOR | Placebo in combination with gemcitabine |
| Name | Type | Description |
|---|---|---|
| IPI-926 | DRUG | Single Arm study of oral IPI-926 at 160 mg, 130 mg or 110 mg daily, until progressive disease or intolerability to study treatments or withdrawal of ICF |
| Placebo Arm | DRUG | oral placebo |
| IPI-926 plus gemcitabine | DRUG | Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle |
| Placebo plus gemcitabine | DRUG | Daily Oral placebo/IPI-926 160 mg plus gemcitabine infusion at 1000 mg/m2 once every 3 weeks in a 28 day cycle |
Inclusion Criteria: * ≥18 years of age at the time of signing the ICF. * Voluntarily sign an ICF. * Pathologically confirmed PMF or post ET/PV MF as per the WHO diagnostic criteria (note that it must include at least Grade 1 marrow fibrosis, see Appendix 3) with intermediate-1, intermediate -2, or ...