Selinexor in the treatment of patients with Refractory and/or Relapsed Richter's Transformatio

Phase 1

• Conditions: Primary Refractory and/or Relapsed Richters Transformation (RT); MedDRA version: 17.0Level: PTClassification code 10058728Term: Richter's syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001240-38-GB
• Lead Sponsor: Karyopharm Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-16
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- male and female patients aged 18 years or older
- willing to sign a written informed consent document
- possess a histologically confirmed diagnosis of DLBCL
- All patients deemed fit for standard chemo-immunotherapy must have received at least one, and no more than two, prior regimens for RT including cytotoxic chemotherapy and anti-CD20 monoclonal antibodies. Patients who are currently deemed unfit for standard cytotoxic chemotherapy must have received one prior therapy, including an anti-CD20 monoclonal antibody therapy.
- One or more measurable (> 1.5 cm in longest dimension) disease sites
- Objective documented evidence of disease progression at study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of = 2
- Baseline platelet count = 30,000/mm3 and absolute neutrophil count = 500/mm3
- Patients who are hepatitis B PCR negative who have a recent (< 6 month) history of IVIG therapy
- Adequate hepatic function: bilirubin = 2 times the upper limit of normal (ULN) and AST and ALT < 2.5 times ULN
- Adequate renal function
- For both male and female patients, effective methods of contraception must be used throughout the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- Patients who are pregnant or lactating
- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy = 2 weeks prior to Cycle 1 Day 1
- Less than 1 month since completion of autologous stem cell transplantation or less than 3 months since completion of allogeneic stem cell transplantation
- Major surgery within four weeks of Cycle 1 Day 1
- Unstable cardiovascular function
- Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose.
- Presence of central nervous system (CNS) leukaemia or lymphoma.
- Known active hepatitis B virus (HBV) or C virus (HCV) infection
- Impairment of gastrointestinal (GI) function or GI disease that could interfere with the absorption of selinexor
- Inability or unwillingness to take supportive medications including a centrally acting appetite stimulant
- Serious psychiatric or medical conditions that could interfere with treatment.
- Participation in an investigational anti-cancer study within 2 weeks prior to Cycle 1 Day 1.
- Concurrent therapy with approved or investigational anticancer therapeutic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified