Clinical trial NCT03466827: Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma
Official title: A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thymoma
Advanced Thymic Epithelial Tumour
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Institut Curie
name: Gustave Roussy, Cancer Campus, Grand Paris
name: Hospices Civils de Lyon
name: GSO Global Clinical Research BV
name: Karyopharm Therapeutics Inc
First posted: 2018-03-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen.

This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (25 patients).

There are two study arms:

Arm A: Thymoma

* Stage 1: 15 patients
* Stage 2: 10 patients

Arm B: Thymic carcinoma

* Stage 1: 15 patients
* Stage 2: 10 patients

Detailed description: Not provided

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: 24 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 6 months
measure: Adverse Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Paris
country: France
facility: Intitut Curie
city: Paris
country: France
facility: Intitut Gustave Roussy
Study officials:
affiliation: Rigshospitalet, Denmark
name: Morten Mau-Soerensen, MD, PhD
role: STUDY_DIRECTOR
References: