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Phase I Trial of Selinexor (KPT-330) and Ifosfamide, Carboplatin, Etoposide (ICE) in Peripheral T-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03212937
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Brief Summary:
This is a single center, open-label, phase I trial with a standard 3+3 dose escalation schema to identify the maximum tolerated dose (MTD) of selinexor when combined with ICE. Once MTD is determined, there will be an expansion phase and tumor biopsies and peripheral blood will be taken pre and post selinexor to examine the study's biologic objectives.

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Drug: Selinexor Drug: ICE Chemotherapy Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Investigator Sponsored Trial of Selinexor (KPT-330), a Selective Inhibitor of Nuclear Export / SINE™ Compound and Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Experimental: Selinexor and ICE Chemotherapy Drug: Selinexor
Oral KPT-330 is administered on Day 3, 5, and 7 of each 21-day cycle. Starting dose is 40mg will be adjusted according to toxicity

Drug: ICE Chemotherapy

IV Ifosfamide 5g/m^2 on Day 2 (inpatient) or D1 (outpatient) of each 21-day cycle

IV Carboplatin AUC 5 on Day 2 (inpatient) or D1-3 (outpatient) of each 21-day cycle

IV Etoposide 100 mg/m^2 on Days 1-3 of each 21-day cycle

Other Name: Ifosfamide, Carboplatin, Etoposide




Primary Outcome Measures :
  1. Number of participants with treatment related dose limiting toxicity as assessed by NCI CTCAE v4.0 [ Time Frame: The first 3 weeks of treatment ]

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: From the start of treatment to the best overall response of Complete or Partial Response is achieved, up to 2 years ]
    Responses will be assessed using the revised International Workshop Criteria

  2. Progression-free survival [ Time Frame: From the start of the treatment to the date of documentation of either disease progression or death, up to 2 years ]
  3. Overall survival [ Time Frame: From the start of treatment to the date of death from any cause, up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed T or NK/T-cell lymphomas including the following histologies:

    • Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS)
    • Angioimmunoblastic T-cell lymphomas (AITL)
    • Anaplastic large cell lymphoma (ALCL)
    • Natural-killer/T-cell lymphoma (NKTL)
  • Patients must have received at least two cycles of one prior regimen administered with curative intent and one of the following:

    • failed to have achieve at least a partial response after 2 or more cycles
    • failed to achieve a complete response after 6 or more cycles
    • progressed after an initial response
    • For patients who have CD30+ anaplastic large cell lymphoma, they must have failed or are ineligible or intolerant of brentuximab vedotin
  • Patients must be age >18 years.
  • Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.
  • Patients must have ECOG performance status of 0-2
  • Patients must have laboratory test results within these ranges:

    • Absolute neutrophil count ≥1500/mm³
    • Platelet count ≥75,000/mm³
    • Creatinine clearance ≥40ml/min
    • Total bilirubin ≤1.5x ULN. Higher levels are acceptable if these can be attributed to active haemolysis or ineffective erythropoiesis.
    • AST (SGOT) and ALT (SGPT) ≤2x ULN
  • Women of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test prior to KPT-330 treatment. Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.

    • Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal.
    • For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.

As the effects of selinexor on the developing human fetus at the recommended therapeutic dose are unknown, women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with selinexor. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women that are pregnant or breastfeeding are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.

  • Patients must be able to understand and willing to sign a written informed consent document.
  • Patients must be able to adhere to the study visit schedule and other protocol requirements.
  • Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

Exclusion Criteria:

  • Patients who have had prior malignancies (other than T and NK/T-cell lymphomas) for ≤5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • Patients who have had other anti-cancer therapy, including radiation or experimental drug or therapy, within 28 days of enrollment.
  • Patients with known HIV, active hepatitis B, active hepatitis C.
  • Patients with known central nervous system involvement by lymphoma.
  • Patients with known or suspected hypersensitivity to selinexor.

Inclusion of Women and Minorities:

Men and women of all ethnic groups are eligible for this study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212937


Contacts
Contact: Tiffany PL Tang +65 6436 8000 tiffany.tang.p.l@singhealth.com.sg
Contact: Shu Qin Toh +65 6436 8000 toh.shu.qin@nccs.com.sg

Locations
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Principal Investigator: Tiffany PL Tang         
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
Principal Investigator: Tiffany PL Tang National Cancer Centre, Singapore

Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT03212937     History of Changes
Other Study ID Numbers: Karyopharm001
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Etoposide phosphate
Isophosphamide mustard
Carboplatin
Etoposide
Ifosfamide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents