Selinexor in Combination With Ixazomib for the Treatment of Advanced Sarcoma
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|ClinicalTrials.gov Identifier: NCT03880123|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Liposarcoma Malignant Peripheral Nerve Sheath Tumors Alveolar Soft Part Sarcoma Ewing Sarcoma Sarcoma||Drug: Selinexor Drug: Ixazomib||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||August 2020|
Patients will receive combination treatment with selinexor and ixazomib. The dose of ixazomib is fixed at 4 mg, whereas several different dose levels of selinexor may be evaluated. No patients will receive a placebo.
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.
Other Name: KPT-330
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.
Other Name: Ninlaro
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 2 years ]To establish the maximum tolerated dose combination for selinexor and ixazomib when used as a combination treatment for patients with dedifferentiated liposarcoma, malignant peripheral nerve sheath tumor, alveolar soft part sarcoma and Ewing sarcoma. The MTD is defined by the time to event continual reassessment method, a model-based dose finding study design.
- Adverse Event (AE) Rate [ Time Frame: Up to 2 years ]Adverse events will be collected from the day the patient receives the first dose of study treatment until 30 days after end-of-treatment. Adverse events will be reported by Common Terminology Criteria for Adverse Events (CTCAE criteria), stratified by grade.
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]The percentage of patients who experience a partial or complete response to study therapy as assessed radiographically by RECIST version 1.1 criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880123
|Contact: Lisa Olmos, RNfirstname.lastname@example.org|
|Contact: Matthew Ingham, MDemail@example.com|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Contact: Matthew Ingham, MD 212-305-5098 firstname.lastname@example.org|
|Principal Investigator: Matthew Ingham, MD|
|Principal Investigator:||Matthew Ingham, MD||Columbia University|