Trial of KPT-330 in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL)
A Multi-center, Phase II, Open-label Study of Efficacy and Safety of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL)
Karyopharm Therapeutics Inc.
30 participants
Mar 11, 2015
Interventional
Conditions
Summary
This study will determine whether selinexor has any effects against Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL). Who is it for? You may be eligible to join this study if you are aged 18 years or above and Relapsed or Refractory PTCL or CTCL Study details This study drug, selinexor, works by trapping “tumour suppressing proteins” within the cell and thus causing the cancer cells to die or stop growing. Selinexor has previously been tested in humans to define a safe dose to be administered. It is not known at this time if selinexor will treat PTCL/CTCL. This study will examine the effects of selinexor on PTCL/CTCL and look at the side-effects. After signing the consent, participants will undergo screening assessments up to 30 days before the first dosing. These include: medical and medication history taking, eye examination, ECG, Echocardiogram or MUGA scan, chest X-ray, CT/MRI scans, tumour or skin biopsy, bone marrow aspirate or biopsy, height, weight, vital signs measurement, physical exam, and urine and safety blood tests. Eligible participants will receive oral selinexor tablets on Days 1 and 3 of Weeks 1-3 of each 4-week (28 day) cycle (6 doses/cycle) until disease progression or intolerability. The dose of selinexor will be either 100mg or 80 mg depending on the participants’ body surface area (calculated from their height and weight). Participants will also take dexamethasone to improve selinexor tolerability and antinausea drugs (e.g. ondansetron) to minimise nausea. Additional anti-nausea and anti-anorexia agents may be given as needed. The assessments done at screening will be repeated at various intervals to monitor safety and assess efficacy of the selinexor. In addition, photographs of skin lesions (CTCL patients only) will be taken and blood samples will be taken to check the level of selinexor in the blood at certain timepoints, and to test the binding of selinexor in the blood. Follow-up visits will occur 30 and 60 days after the last dose of selinexor, then participants will be contacted every 3 months to check on their disease status and other treatments.
Eligibility
Inclusion Criteria5
- Adult patients 18 years of age or older and providing informed consent
- ECOG performance status of less than or equal to 2.
- Relapsed or refractory to previous treatment of PTCL/CTCL
- Acceptable organ function
- Non pregnant or not breastfeeding
Exclusion Criteria13
- Known active central nervous system (CNS) lymphoma.
- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy (except glucocorticoids) less than 4 weeks prior to Cycle 1 Day 1, and radio-immunotherapy 6 weeks prior to Cycle 1 Day 1.
- Have not adequately recovered from the side effects of previous antineoplastic agents prior to dosing.
- Active graft-versus-host disease after allogeneic stem cell transplantation.
- Autologous stem cell transplantation less than 100 days prior to Cycle 1 Day 1
- Concurrent therapy with approved or investigational anti-cancer drugs
- Major surgery within last 2 weeks
- Any other significant concomitant illness
- Unstable cardiovascular function
- Uncontrolled infection
- Active HIV or hepatitis infection
- Serious psychiatric or medical condition
- Unable to swallow capsules
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Interventions
Oral selinexor tablet 100 mg or 80 mg taken on Days 1 and 3 of Weeks 1-3 of each 4-week [28 day] cycle [6 doses per cycle] until disease progression or intolerability. Participants with a Body Surface Area (BSA) of 1.7 or greater will be given 100mg of selinexor. Participants with a BSA less than 1.7 and greater than or equal to 1.35 will be given 80mg of selinexor. Oral Dexamethasone tablet (12mg or 8mg in participants with intolerance) will be given with each dose of selinexor. To minimise nausea, all participants will be given anti-nausea medication (e.g. ondansetron 8 mg tablet or equivalent) starting on Day 1 before the first dose of selinexor and continued twice or three times a day as needed. Participants will be asked to return all the provided study medication at each study visit. The study site staff will account for the number of tablets dispensed against those return by the participant.
Locations(4)
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ACTRN12614001328662