Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors
This study has been completed.
Information provided by (Responsible Party):
First received: April 2, 2013
Last updated: July 26, 2016
Last verified: May 2016
Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors
Head and Neck Carcinoma
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Non-squamous Cell Lung Cancer
Drug: PM01183 + paclitaxel +/- bevacizumab
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors
Primary Outcome Measures:
- To determine the maximum tolerated dose (MTD) and the recommended dose (RD) [ Time Frame: Around 24 months from the begining of the study ] [ Designated as safety issue: Yes ]
To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab, in patients with selected advanced solid tumors.
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: Around 24 monts after the begining of the study ] [ Designated as safety issue: No ]
To characterize the pharmacokinetics (PK) and to detect major drug-drug PK interactions
- Preliminary antitumor activity. [ Time Frame: Every nine weeks, up to around 24 months from the begining of the study ] [ Designated as safety issue: No ]
Antitumor activity will be measured clinically and/or radiologically according to the RECIST (Response Evaluation Criteria in Solid Tumors)
- Information on quality of life (QoL) [ Time Frame: baseline, 9, 18 and 24 weeks ] [ Designated as safety issue: No ]
Changes in Quality of Life scores over time will be evaluated according to the European Organization for Research and Treatment of Cancer (EORTC) questionnaire EORTC-QLQ-C15-pal
- Pharmacogenomic (PGx) [ Time Frame: Around 24 months from the begining of the study ] [ Designated as safety issue: No ]
Identification and validation of putative molecular markers associated with the clinical outcome of treated patients
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2016 (Final data collection date for primary outcome measure)
PM01183 + paclitaxel +/- bevacizumab
Drug: PM01183 + paclitaxel +/- bevacizumab
PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion
paclitaxel: 6 mg/ml concentrate for solution for infusion
bevacizumab: 25 mg/ml concentrate for solution for infusion
Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients
Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a selected cohort of patients to characterize the safety profile and feasibility of this combination, to obtain preliminary information on antitumor activity, to obtain preliminary information on quality of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to detect major drug-drug PK interactions and PK/PD (pharmacokinetic/pharmacodynamic) correlation and to conduct an exploratory pharmacogenomic(PGx) analysis in patients with selected advanced solid tumors.
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Prior treatment with PM01183 or weekly paclitaxel or nanoalbumin-paclitaxel
- Patients who have previously discontinued paclitaxel-based regimes due to drug related toxicity.
- Known hypersensitivity to bevacizumab or any component of its formulation
- Patients who have previously discontinued bevacizumab-containing regimes due to drug-related toxicity.
- More than three prior lines of chemotherapy
- Less than three months since last taxane-containing therapy.
- Less than three weeks since the last chemotherapy-containing regimen
- Less than three weeks since the last radiotherapy dose
- Less than four weeks since last monoclonal antibody-containing therapy
- Concomitant diseases/conditions:
Unstable angina, myocardial infarction, valvular heart disease, encephalopathy, ischemic attacks, hemorrhagic or ischemic cerebrovascular accident (CVA) or ongoing pulmonary embolism within last year, arrhythmia, hepatopathy, uncontrolled infection, hemoptysis or oxygen requiring dyspnea, known HIV infection, bleeding risk, muscular problems, peripheral neuropathy, Symptomatic or progressive brain metastases or leptomeningeal disease.
- Men or pre-menopausal women who are not using an effective method of contraception as previously described; actively breast feeding women.
- Patients who have pelvic irradiation with doses ≥ 45 Grays (Gy).
- History of previous bone marrow and/or stem cell transplantation.
- Confirmed bone marrow involvement
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01831089
|New York, New York, United States |
|Madrid, Spain |
|Bellinzona, Switzerland |
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 2, 2013
||July 26, 2016
||United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Angiogenesis Modulating Agents
Physiological Effects of Drugs