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Pixantrone

Enzyme Inhibitors

Each patient will receive pixantrone monotherapy administered intravenously once on days 1, 8, and 15 up to six 28-day cycles of pixantrone monotherapy, with two additional cycles in patients who continue to benefit from treatment. At least 6 patients each from Age Cohorts 1 and 2 will be accrued into dose escalation cohorts. The study will be opened to patients of Age Cohort 3 only after at least 6 patients in Age Cohorts 1 and 2 (combined) have been evaluated for toxicity. During the dose escalation phase, participants who are inevaluable for DLT for reasons unequivocally unrelated to toxicity will be replaced. Expansion cohort accrual quota-At least 15 evaluable patients treated with the MTD/optimal dose will be accrued in total, of which 7 patients will be in Age Cohort 2.

Leo Mascarenhas, MD. MS.

This is a phase 1, open-label, dose escalation study to evaluate the safety, pharmacokinetics, and antitumor activity of pixantrone in pediatric patients with relapsed or refractory solid tumors (excluding those with CNS tumors) or lymphoma.

Approximately thirty-five eligible patients will receive up to six 28-day cycles of pixantrone monotherapy, with two additional cycles in patients who continue to benefit from treatment. Each patient will receive pixantrone administered intravenously on days 1, 8, and 15 of each 28-day cycle. There will be three age cohorts, defined as age cohort 1 (12 to less than 18 years, plus young adults (ages 18-21 years)), age cohort 2 (5 to less than 12 years), and age cohort 3 (6 months to less than 5 years). During dose escalation, three patients will first be accrued to the starting dose level. If no DLTs are identified, that dose level will be declared to not exceed the MTD and three patients will be accrued to the next higher dose level. Each subsequent dose-escalation level will be accrued per the DLT/MTD determination schema above. Planned sequential dose-escalation phase will receive 40 mg/m2, 50 mg/m2, 60 mg/m2 or 70 mg/m2 of pixantrone base (on days 1, 8 and 15), as tolerated, based on DLT evaluation.Dose escalations will follow a standard 3+3 patient cohort escalation plan. No patients from Age Cohort 3 will be enrolled until 6 patients from age cohorts 1 and 2 (combined) are evaluable for toxicity. After the MTD has been determined, an expansion phase will be accrued in order to gain better estimates of the safety, tolerability, and anti-tumor activity of pixantrone monotherapy in pediatric patients when treated at the MTD. Patients will be offered 3 years of post-study extension phase follow-up with periodic assessments of cardiac function parameters.

Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory Cancer

A Phase 1, Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory Cancer

Dose Escalation- The study will follow a standard 3+3 patient cohort escalation design, evaluating up to 4 dose levels.

Dose Expansion Cohort- Anti-tumor activity will be summarized by disease type, dose level, and age cohort for all patients in the evaluable population. The best overall response rate, defined as the proportion of patients that achieved a complete or partial response, will be summarized by disease type and a 95% confidence interval will be provided. A similar summary will be provided for the complete response rate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory Cancer	NCT02800889	Lymphoma Solid Tumor (Ex...	Pixantrone	6 Months - 21 Years	CTI BioPharma
Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory Cancer	NCT02800889	Lymphoma Solid Tumor (Ex...	Pixantrone	6 Months - 21 Years	CTI BioPharma

Spots Global Cancer Trial Database for solid tumor (excluding cns)