A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Patients with Recurrent Gliomas - KING

Karyopharm Therapeutic, Inc.0 sites76 target enrollmentNovember 12, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent glioblastoma or other brain cancer after failure of radiation therapy and temozolomide
Sponsor: Karyopharm Therapeutic, Inc.
Enrollment: 76
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

November 12, 2013

End Date

January 23, 2020

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Karyopharm Therapeutic, Inc.

•1\. Pathologically confirmed diagnosis of GBM (including all histologic variants) with radiographic evidence of recurrent disease after treatment with radiotherapy and temozolomide;
•2\. Age \= 18 years;
•3\. Karnofsky Performance Status (KPS) \= 60;
•4\. Patients enrolling in the medical arm (Arms B, C, or D) must be on a stable or decreasing dose of corticosteroids (or none) for at least 5 days prior to the baseline CT/MRI;
•5\. Patients must have received prior treatment with radiation therapy and temozolomide (all arms);
•6\. Measurable disease (according to RANO guidelines, within 14 days of starting treatment). Measurable disease after surgery on arm A is not required.
•7\. Written informed consent obtained prior to any screening procedures. Patients must be willing and able to comply with the protocol and aware of the investigational nature of this study.
•8\. Patients must have adequate bone marrow function and organ function within 2 weeks of study treatment as defined by the following laboratory criteria;
•o Hematopoietic function: total white blood cell count (WBC) \= 3000/mm³, absolute neutrophil count (ANC) \= 1500/mm³, platelet count \= 125,000/mm³; hemoglobin \= 9g/dL
•o Hepatic function: bilirubin \< 1\.5 times the upper limit of normal (ULN), ALT \< 2\.0 times ULN, AST \< 2\.0 times ULN; unless bilirubin elevation is related to Gilbert’s Syndrome for which bilirubin must be \<4 times ULN.

•1\. Patients must not have 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.
•2\. \<24 days from prior temozolomide, \<6 weeks from nitrosourea, \<4 weeks from other chemotherapy or investigational agents prior to start of treatment within study.
•3\. Unstable cardiovascular function.
•4\. Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); hepatitis testing is not required.
•5\. Known HIV infection; HIV testing is not required.
•6\. Markedly decreased visual acuity if attributed to other causes than GBM.
•7\. Active infection requiring parenteral systemic antibiotics.
•8\. Patients with coagulation problems and medically significant bleeding in the month prior to start of treatment (e.g., peptic ulcer, epistaxis, spontaneous bleeding). Prior history of DVT or PE is not exclusionary.
•9\. Patients who are pregnant or breast\-feeding.
•10\. Other cancer (except non\-melanoma skin cancer or carcinoma in\-situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.