University of Alabama at Birmingham
A multi-institutional open-label phase 1/2 trial of selumetinib in combination with ZEN-3694 and durvalumab in refractory/unresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory/relapsed sarcomas. The phase 2 portion will be for patients with refractory/unresectable NF1-associated MPNST.
A multi-institutional open-label phase 1/2 trial of selumetinib in combination with bromodomain inhibitor (ZEN-3694) and durvalumab in refractory/unresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory/relapsed sarcomas. The phase 2 portion will be for patients with refractory/unresectable NF1-associated MPNST. Part A will be a phase 1 dose escalation study of the combination with selumetinib and ZEN-3694. Part B will be phase 1 study combining the determined dose of selumetinib and ZEN-3694 from Part A with d…
Inclusion Criteria: Inclusion Criteria AGE: ≥ 18 years of age Weight: \>30 kg Life expectancy of at least 12 weeks Part A and B (Phase 1): Patients with histologically confirmed soft tissue or bone sarcoma of the following subtypes: * MFH/ undifferentiated pleomorphic sarcoma * Unclassified sarcoma * Rhabdomyosarcoma * Malignant peripheral nerve sheath tumor (MPNST) * Osteosarcoma * Ewing or Ewing-like sarcoma * Synovial sarcoma * Desmoplastic small round blue cell tumor (DSRCT) Patients must have progressed or demonstrated disease that is refractory to standard therapies. Patients for wh…
Selumetinib and ZEN-3694 administered per protocol, with durvalumab added in later study parts.
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