NCT03880123

Selinexor in Combination With Ixazomib for the Treatment of Advanced Sarcoma

A Phase I Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor in Combination With the Proteasome Inhibitor Ixazomib for the Treatment of Advanced Sarcoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Matthew Ingham · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to establish a safe and tolerable dose combination (the "maximum tolerated dose") of selinexor and ixazomib when used together for the treatment of patients with certain types of advanced sarcoma. The study will enroll patients with advanced dedifferentiated liposarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma and Ewing sarcoma. Future studies to further evaluate the safety and anti-cancer efficacy of this treatment for sarcoma will use the dose combination determined in this study.

Detailed description

Sarcoma is a rare form of cancer which originates from the soft tissues and bones of the body. There are more than 50 different types of sarcoma. The primary treatment approach for most types of advanced sarcoma involves chemotherapy, but newer treatment approaches are needed because chemotherapy is not curative, sometimes does not work well, and often has significant side effects. The purpose of this study is to evaluate a new treatment for certain types of sarcoma. The new treatment involves two oral targeted drugs used in combination: selinexor and ixazomib. Selinexor inhibits the transport of certain proteins between the nucleus and the cytoplasm of the cell. Ixazomib is part of a class of drugs called proteasome inhibitors. Currently, neither of these drugs is approved for the treatment of sarcoma. The researchers believe this combination treatment may work effectively for certain types of sarcoma based on encouraging laboratory research results. The types of sarcoma in which the treatment will be tested are: dedifferentiated liposarcoma, alveolar soft part sarcoma, malignant peripheral nerve sheath tumor, and Ewing sarcoma. The purpose of this study is to define doses of selinexor and ixazomib that are safe and tolerable for patients.

Conditions

• Liposarcoma
• Malignant Peripheral Nerve Sheath Tumors
• Alveolar Soft Part Sarcoma
• Ewing Sarcoma
• Sarcoma

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor will be taken orally on Days 1, 8, 15, and 22 of each cycle at the following dose levels (DLs): DL 1: 40 mg; DL 2: 60 mg; DL 3: 80 mg; DL 4: 100 mg The selinexor product is provided as 20 mg tablets in wallet-sized blister packs. Selinexor should be taken together with ixazomib.
DRUG	Ixazomib	Ixazomib will be taken orally on Days 1, 8, and 15 of each cycle at the same dose level: 4 mg. The ixazomib product is provided in strengths of 4.0, 3.0, and 2.3 mg capsules as the active boronic acid. Ixazomib should be taken on an empty stomach (no food or drink) at least 1 hour before or at least 2 hours after food.

Timeline

• Start date: 2020-11-01
• Primary completion: 2020-11-24
• Completion: 2020-11-24
• First posted: 2019-03-19
• Last updated: 2020-11-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study