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Phase 2 Completed N=38 Treatment

Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma

Source: ClinicalTrials.gov NCT00550615 ↗
Enrolled (actual)
38
Serious AEs
48.5%
Results posted
Feb 2019
Primary outcomePrimary: Maximum Tolerated Dose — 200 milligrams PO daily

Summary

Primary Objective: * To determine the maximum tolerated dose (MTD) of Dasatinib in relapsed or refractory non-hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL. Secondary Objectives: * To assess the complete and overall response rates for all Phase I and Phase II patients and to determine overall survival and event free survival for all Phase I and Phase II patients. * To assay the levels of kinase activity in NHL specimens and correlate this activity to patient outcomes.

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Tolerated Dose
200
SECONDARY
Number of Participants With Clinical Response Rates
7; 17

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of non-hodgkin's lymphoma that is recurrent or refractory after at least one prior therapy and for which no other potentially curative therapy is available.
  • Subject, age > or = 19 years
  • Performance status (ECOG) 0-2
  • Patients must have relapsed or refractory disease after at least one prior systemic therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen. Recover to ≤ grade 1 from all toxicities related to the prior treatments is required.
  • Patients must be ineligible or relapsed after an autologous or allogeneic stem cell transplant if clinically appropriate.
  • Adequate Laboratory Parameters:
  • ANC ≥ 1000/μL
  • Platelet count ≥ 50,000/μL
  • Total bilirubin 450 msec)
  • Subjects with hypokalemia or hypomagnesemia if it cannot be corrected
  • History of significant bleeding disorder unrelated to cancer, including:
  • Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
  • Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
  • Ongoing or recent (< or = 3 months) significant gastrointestinal bleeding
  • Concomitant Medications, consider the following prohibitions:
  • Drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib.) quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide,erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
  • The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy.
  • Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy
  • Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
  • Patient may not be receiving any prohibited CYP3A4 inhibitors
  • Women:
  • Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks 6 months after cessation of study drug
  • Have a positive pregnancy test at baseline
  • Are pregnant or breastfeeding
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00550615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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