Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01970540|
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Adenocarcinomas Neuroendocrine Tumors Small-cell Lung Cancer With Less Than 2 Prior Cytotoxic-containing Lines of Therapy||Drug: lurbinectedin (PM01183) Drug: Doxorubicin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination With Doxorubicin in Non-heavily Pretreated Patients With Selected Advanced Solid Tumors|
|Actual Study Start Date :||May 25, 2011|
|Actual Primary Completion Date :||August 9, 2017|
|Actual Study Completion Date :||August 9, 2017|
|Experimental: lurbinectedin (PM01183) / doxorubicin||
Drug: lurbinectedin (PM01183)
lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
- Recommended Dose (RD) [ Time Frame: 18 months ]The RD will be the highest dose level explored in which less than one third of evaluable patients experience a Dose Limiting Toxicity (DLT) during Cycle 1.
- Pharmacokinetics (PK) characterisation [ Time Frame: 18 months ]The dose-exposure relationships for maximum plasma concentration (Cmax) and area under the curve (AUC) will be evaluated.
- Pharmacogenomic (PGx) analysis [ Time Frame: 18 months ]Pharmacogenomics will be evaluated in order to determine predictive/prognostic markers of response and/or resistance to PM01183 and doxorubicin.
- Preliminary antitumor efficacy [ Time Frame: 42 months ]Recommended Dose expansion is ongoing in selected tumor types in order to confirm preliminary evidence of activity, specifically the study is recruiting patients with neuroendocrine tumors (NETs), or endometrial adenocarcinomas or SCLC (with less than 2 systemic chemotherapy-containing prior lines of therapy)
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): NCT01970540
|Hospital Universitari Vall D'Hebron|
|Barcelona, Spain, 08035|
|Centro Oncológico Md Anderson International España|
|Madrid, Spain, 28033|
|Hospital Ramón Y Cajal|
|Madrid, Spain, 28034|
|Hospital Universitario Fundación Jiménez|
|Madrid, Spain, 28040|
|Hospital Universitario Madrid Sanchinarro|
|Madrid, Spain, 28050|
|Fundación Instituto Valenciano de Oncología|
|Valencia, Spain, 46009|
|UCLH (University College London Hospitals)|
|London, United Kingdom, WC1E 6DB|