EUCTR2014-001240-38-GB
Active, not recruiting
Phase 1
A Phase 2 Study of the Safety and Anti-tumor Activity of the Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients with Refractory and/or Relapsed Richter’s Transformation (RT). - SIRRT (Selinexor in Relapsed/Refractory Richters Transformation)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Karyopharm Therapeutics Inc.
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Richters TransformatioInitial and Refractory/Relapsed Richters Transformation (RT)MedDRA version: 18.0Level: PTClassification code 10058728Term: Richter's syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-001240-38-DEKaryopharm Therapeutics, Inc.50
Active, not recruiting
Phase 1
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defectMedDRA version: 20.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-000345-39-NLPfizer Inc., 235 East 42nd Street, New York, NY 10017541
Completed
Phase 2
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant TumorsNL-OMON48840Pfizer22
Active, not recruiting
Phase 1
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defectMedDRA version: 20.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-000345-39-FRPfizer Inc., 235 East 42nd Street, New York, NY 10017541
Active, not recruiting
Phase 1
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant TumorsEUCTR2018-000345-39-ITPFIZER INC541