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Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183.
Full description
Open-Label, Dose-Escalating, Clinical and Pharmacokinetic Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered as 1-hour intravenous (i.v.) infusion on three consecutive days (Days 1-3) to patients with advanced acute leukemia and to assess the safety profile and tolerability, to obtain preliminary information on the efficacy and to characterize the pharmacokinetics (PK) and pharmacogenomic (PGx) profile of PM01183.
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Inclusion criteria
Voluntarily signed and dated written informed consent
Age ≥ 18 years.
Patients must have a previous cytological or histological diagnosis of:
Patients must have the following laboratory values prior to the start of treatment:
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Negative pregnancy test for women of childbearing potential.
Exclusion criteria
Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods throughout the treatment period and for six months after discontinuation of treatment.
Patients who plan to undergo allogeneic BM transplantation within four weeks.
Other relevant diseases or adverse clinical conditions:
Hematopoietic allogeneic stem cell transplantation within the last four months and/or active graft versus host disease, or prior autologous transplantation within the last four weeks.
Patients known to be human immunodeficiency virus (HIV) positive.
Cytotoxic chemotherapy within the last two weeks; radiation therapy within the last two weeks; biologic agents, including hematopoietic growth factors, within the last week; hydroxyurea, imatinib, corticosteroids and arsenic trioxide should be discontinued at least 24 hours prior to first study drug administration.
Treatment with any investigational product in the ≤ 5 half-lives period prior to inclusion in the study, or 30 days after therapy (in case of unknown half-life), unless evidence of rapid proliferating disease and upon discussion with the Sponsor.
Known hypersensitivity to any of the components of the drug product (DP).
45 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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