Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT04595994|
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : July 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma,Soft Tissue||Drug: Selinexor||Phase 1|
Phase I-II, randomized, open-label, multicenter, international clinical trial Patients with advanced soft-tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft-part sarcoma) and osteosarcoma will receive selinexor in combination with gemcitabine.
In the Phase I part safety and toxicity of the combination will be assessed using a 3+3 design. The recommended dose for the Phase II will be determined.
In the Phase II part there will be 4 different cohorts:
Cohort 1: Undifferentiated pleomorphic sarcoma (UPS) Cohort 2: Leiomyosarcoma (LMS) Cohort 3: Alveolar soft-part sarcoma (ASPS) Cohort 4: Osteosarcoma Patients will be randomized for phase II part only (except in cohort 3) in an open-label way to receive selinexor in combination with gemcitabine versus gemcitabine alone
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||unique arms for each possible dose|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma|
|Actual Study Start Date :||September 2, 2020|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||July 1, 2024|
Experimental: Selinexor + Gemcitabine
Dose escalation levels (Phase I):
All included patients will take both drugs:
Selinexor weekly (given on days 1,8 and 15 of each cycle) will be dispensed at different dose levels: dose level 1:60 mg, dose level 2: 60 mg, dose level 3: 60 mg, and dose level 4: 80 mg).
Gemcitabine weekly (given on days 1, 8 of each cycle) will be administered at different dose levels: (dose level 1:1000 mg/m2 (30 min), dose level 2:1000 mg/m2 (10 mg/m2/min), dose level 3:1200 mg/m2 (10 mg/m2/min) and dose level 4: 1200 mg/m2 (10 mg/m2/min)).
Selinexor: tablet (20 mg tablets) Oral use.
Gemcitabine: Concentrate for solution for infusion. Intravenous use.
For both interventional ( Selinexor and Gencitabine) Dose-limiting toxicity (DLT) will be applied only to either of the following toxicities occurring during the first treatment cycle (days 1-21).
Other Name: Gemcitabine
- Maximum tolerated dose (MTD) [ Time Frame: 6 months ]To determine the maximum tolerated dose (MTD) or the recommended dose for phase II of Selinexor plus gemcitabine.
- Safety profile according to CTCAE 5.0. [ Time Frame: 6 months ]Safety profile of the experimental treatment, through assessment of adverse event type, incidence, severity, time of appearance, related causes, as well as physical explorations and laboratory tests.
- Objective response rate (ORR). [ Time Frame: 6 months ]Objective Response Rate (ORR): ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects (according to RECIST 1.1 criteria).
- Evaluate efficacy according to Choi response [ Time Frame: 6 months ]Efficacy measured through tumor response according to Choi criteria. The evaluation criteria will be based on the identification of target lesions in baseline and their follow-up until tumor progression.
- Patients's quality of life (QoL) [ Time Frame: 6 months ]Quality of life will be measured with European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire 30
- Pharmacokinetic values in blood analysis [ Time Frame: 6 months ]Impact of pharmacokinetics. interactions between selinexor in gemcitabine
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): NCT04595994
|Contact: Guiomar Rodriguez Beloso||+34 971 439 email@example.com|
|Contact: Margalida Frau||+34 971 439 firstname.lastname@example.org|
|HU Vall d'Hebron||Active, not recruiting|
|Barcelona, Spain, 08035|
|H. Fundación Jiménez Díaz||Recruiting|
|Madrid, Spain, 28040|
|Contact: Javier Martín Broto, MD email@example.com|
|Principal Investigator: Javier Martín Broto, MD|
|Hospital Clínico San Carlos||Recruiting|
|Madrid, Spain, 28040|
|Contact: Antonio Casado, MD firstname.lastname@example.org|
|Hospital Universitario La Paz||Recruiting|
|Madrid, Spain, 28046|
|Contact: Andrés Redondo, MD email@example.com|
|Hospital Universitario Miguel Servet||Recruiting|
|Zaragoza, Spain, 50009|
|Contact: Javier Martínez Trufero, MD|
|Study Director:||Javier Martín Broto, MD||Hospitales Universitarios Virgen del Rocío|