Selinexor in Advanced Liposarcoma (SEAL)
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| ClinicalTrials.gov Identifier: NCT02606461 |
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Recruitment Status :
Active, not recruiting
First Posted : November 17, 2015
Last Update Posted : November 24, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dedifferentiated Liposarcoma | Drug: Selinexor Drug: Placebo | Phase 2 Phase 3 |
In the Phase 2 portion of the study, 57 patients were randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio.
In the Phase 3 portion of the study, approximately 277 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio.
Patients who progress during the blinded portion of the study will be unblinded and if receiving:
- placebo, may cross over to open-label selinexor (60mg twice weekly)
- selinexor, will be withdrawn from further treatment and followed for survival
Study treatment will be given twice weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability.
Treatment will continue until one or more of the following occurs:
- Disease progression, as defined by RECIST v1.1 Response Criteria
- Clinical progression, as determined by the treating physician
- Unacceptable AEs or failure to tolerate study treatment
- Patient withdrawal
- Patient discontinuation due to non-compliance
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 342 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS) |
| Study Start Date : | December 2015 |
| Estimated Primary Completion Date : | November 2020 |
| Estimated Study Completion Date : | April 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Selinexor 60mg
Phase 2: 57 patients were randomized to selinexor or placebo in a 1:1allocation. Phase 3: Approximately 277 patients will be randomized to selinexor (~185 patients) or placebo (~92 patients) in a 2:1 allocation. |
Drug: Selinexor
Selinexor 60mg
Other Name: KPT-330 |
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Placebo Comparator: Placebo
Phase 2: Approximately 57 patients were randomized to selinexor or placebo in a 1:1 allocation. Phase 3: Approximately 277 patients will be randomized to selinexor (~185 patients) or placebo (~92 patients) in a 2:1 allocation. |
Drug: Placebo
Other Name: sugar pill |
- Assess and compare Progression-free Survival (PFS) of patients with advanced unresectable DDLS treated with selinexor (60 milligrams [mg]) or placebo. [ Time Frame: From the date of randomization until the first date of disease progression, per RECIST v1.1 Response Criteria, or death due to any cause; up to approximately 30 months. ]
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients ≥12 years of age
- Body surface area (BSA) ≥ 1.2 m2
- Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment
- Must have measurable disease per RECIST v1.1 Response Criteria
- Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy
- Must have had at least two (2) prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)
- If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug - whichever is shorter) with all clinically significant therapy- related toxicities having resolved to less than or equal to Grade 1
Exclusion Criteria:
- Patients with pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes.
- Known active Hepatitis B (HepB), Hepatitis C (HepC) or human immunodeficiency virus (HIV) infection.
- Known central nervous system metastases
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): NCT02606461
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| Study Director: | Michael Kauffman, MD, Ph.D | Karyopharm Therapeutics Inc |
| Responsible Party: | Karyopharm Therapeutics Inc |
| ClinicalTrials.gov Identifier: | NCT02606461 |
| Other Study ID Numbers: |
KCP-330-020 2015-003594-14 ( EudraCT Number ) |
| First Posted: | November 17, 2015 Key Record Dates |
| Last Update Posted: | November 24, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
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Advanced unresectable dedifferentiated liposarcoma selinexor KCP-330 Karyopharm |
Phase 2 / 3 dedifferentiated liposarcoma Liposarcoma |
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Liposarcoma Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Sarcoma |