Clinical Study of PM01183 in Patients With Acute Leukemia or Relapsed/Refractory Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT01314599|
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : November 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia||Drug: PM01183 1 mg Powder for concentrate for solution for infusion and PM01183 4 mg Powder for concentrate for solution for infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Dose-Escalating, Clinical and Pharmacokinetic Phase I Study of Lurbinectedin (PM01183) in Patients With Advanced Acute Leukemia or Relapsed/Refractory Myelodysplastic Syndrome.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Arm 1
PM01183 will be administered i.v. as a 1-hour infusion through a pump device at escalating doses according to the respective dose level, on Days 1 and 8 of each treatment phase.
Drug: PM01183 1 mg Powder for concentrate for solution for infusion and PM01183 4 mg Powder for concentrate for solution for infusion
PM01183 Drug Product will be provided as a lyophilized powder for concentrate for solution for infusion with a strength of 1.0 mg/vial and 4.0 mg/vial.
Before use, the vials will be reconstituted with 2 ml or 8 ml of sterile water for injection to give a solution containing 0.5 mg/ml of PM01183.
- Maximum Tolerated Dose (MTD) and Recommended Dose (RD) of PM01183 in patients with advanced acute leukemia. [ Time Frame: Up to 30 months ]The recommended dose (RD) will be the immediate lower DL below the MTD (maximum tolerated dose)with less than 1/3 of the first 6 evaluable patients experiencing DLT (dose limiting toxicity)during the induction, provided the RD is ≥ dose level 2. If the RD is determined at dose level 1, no further expansion will be done, and the study will be terminated.
- Antileukemic activity [ Time Frame: After induction/reinduction and every 4 weeks after treatment discontinuation; up to 30 months ]Activity will be defined according to the International Working Group (IWG) criteria.
- Pharmacogenomic (PGx) profile of PM01183 in patients with advanced acute leukemia. [ Time Frame: Between day -24 to day 1 ]Identification of potential biomarkers of response to PM01183
- Pharmacokinetics (PK) of PM01183 in patients with advanced acute leukemia [ Time Frame: Days 1 to 8 of induction and day 1 of next phase ]The PK will be elucidated using standard non-compartmental methods. The following parameters will be calculated: maximum drug concentration (Cmax), area under the curve (AUC), volume of distribution based on the terminal half-life (Vz), volume of distribution at steady state (Vss), clearance (CL) and half-life (t1/2)
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): NCT01314599
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Texas|
|Houston, Texas, United States, 77030|