Status:
UNKNOWN
Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma
Lead Sponsor:
Morten Mau-Soerensen
Collaborating Sponsors:
Institut Curie
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Thymoma
Advanced Thymic Epithelial Tumour
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic...
Detailed Description
Not provided
Eligibility Criteria
Inclusion
- Histologically confirmed advanced TET (thymoma or thymic carcinoma)
- Inoperable per local Investigator (Masaoka Stage III or IV)
- Progression after treatment with least one platinum containing chemotherapyregimen
- Measurable disease (RECIST 1.1)
- Age ≥18 years
- ECOG PS \<2
- Patients must have recovered from the toxic effects of prior therapy at the time of initiation of the study drug unless toxicity is stable.
- A 4 weeks interval from any investigational agents or cytotoxic chemotherapy to start of study is required
- Signed informed consent
- Adequate bone marrow function and organ function:
- Hematopoietic function: total white blood cell count (WBC) ≥ 3000/mm³, absolute neutrophil count (ANC) ≥ 1500/mm³, platelet count ≥ 100,000/mm²
- Hepatic function: bilirubin \< 1.5 times the upper limit of normal (ULN), ALT \< 2.5 times ULN or ALT \< 5.0 times ULN in the presence of liver metastases
- Creatinine clearance \> 30 ml/min according to Cockcroft-Gault
- Patients of childbearing potential must agree to use adequate birth control during and for 3 months after participation in this study
Exclusion
- No significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy, including
- Unstable cardiovascular function
- Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
- Markedly decreased visual acuity
- Active infection requiring intravenous antibiotics
- Pregnancy or breast-feeding
- Symptomatic brain metastasis requiring corticosteroids
- Uncontrolled autoimmune disorders. Patients with autoimmune disorders under control on medication may be included. Patients with pure red cell aplasia may be included if haemoglobin levels are relatively stable on transfusions or medication
- Any other cancer (excluding radically operated localised squamous skin cancer) with clinical activity within the last 2 years
- Significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications
- No dehydration of NCI-CTCAE grade ≥ 1
- Serious psychiatric or medical conditions that could interfere with treatment.
- No history of organ allograft
- No concurrent therapy with approved or investigational anticancer therapeutics
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03466827
Start Date
October 12 2017
End Date
July 1 2020
Last Update
March 15 2018
Active Locations (4)
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1
Rigshospitalet
Copenhagen, Denmark, 2100
2
Hospices Civils de Lyon
Lyon, France
3
Intitut Curie
Paris, France
4
Intitut Gustave Roussy
Paris, France