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A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01951157
First Posted: September 26, 2013
Last Update Posted: December 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PharmaMar
  Purpose
A clinical study of lurbinectedin(PM01183) alone or in combination with gemcitabine in comparison to docetaxel for the treatment of unresectable non-small cell lung cancer (NSCLC)patients

Condition Intervention Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: Docetaxel Drug: Gemcitabine Drug: Lurbinectedin (PM01183) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination With Gemcitabine and a Control Arm With Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Primary Outcome Measures:
  • Progression-free survival rate at four months (PFS4) [ Time Frame: At month four after patient inclusion ]
    The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (~4 months) after randomization


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 12 months after last patient inclusion ]
    Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact

  • Information on quality of life (QoL) [ Time Frame: At screening and every three cycles ]
    Changes of patient's quality of life followed by a lung cancer symptom scale (LCSS)questionnaire score

  • Pharmacogenomic (PGx) [ Time Frame: 12 months after last patient inclusion ]
    Potential correlations between clinical outcomes achieved with PM01183-based treatment and molecular parameters found in previous available tumor and blood samples


Enrollment: 69
Study Start Date: October 2013
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A - docetaxel
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Drug: Docetaxel
Powder for solution for infusion
Experimental: B - lurbinectedin (PM01183)
3.2 mg/m2 PM01183, day 1, 1-hour intravenous, every three weeks
Drug: Lurbinectedin (PM01183)
Powder for concentrate for solution for infusion
Experimental: C - gemcitabine + lurbinectedin (PM01183)
800 mg/m2 gemcitabine / 1.6 mg/m2 PM01183 both on day 1 and day 8, 30-minutes gemcitabine/1-hour PM01183 intravenous, every three weeks
Drug: Gemcitabine
Powder for solution for infusion
Drug: Lurbinectedin (PM01183)
Powder for concentrate for solution for infusion

Detailed Description:
A randomized-controlled, three-arm, phase II study of lurbinectedin (PM01183) alone or in combination with gemcitabine and a control arm with docetaxel as second-line treatment in unresectable non-small cell lung cancer (NSCLC)patients to evaluate the antitumor activity as progression-free survival at four months (PFS4) of PM01183 alone or in combination with gemcitabine as using single agent docetaxel as a reference in the control arm as current standard of care and to analyze overall survival (OS), overall survival rate at 1-year (OS12), duration of response (DR), antitumor activity, as response rate (RR), safety and efficacy profiles of PM01183 alone and in combination with gemcitabine, to be preliminary compared with docetaxel, patients' quality of life (QoL), pharmacokinetics (PK) of PM01183, pharmacokinetic/pharmacodynamic (PK/PD)correlation and pharmacogenomics (PGx)to explore potential correlations between clinical outcomes and molecular parameters found in tumor and blood samples
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed unresectable NSCLC
  • Patients must have failed one prior line of CT-based therapy for unresectable disease
  • Age between 18 and 75 years
  • Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1
  • Adequate hematological, renal, metabolic and hepatic function
  • At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy
  • Negative pregnancy test for pre-menopausal women

Exclusion Criteria:

  • Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled infection, pleural or pericardial effusions, myopathy, limitation of the patient's ability to comply with the treatment or to follow-up the protocol, any other major illness
  • Histological features of neuroendocrine or bronchioalveolar differentiation.
  • Unknown epidermal growth factor receptor (EGFR)mutation status or previously known EGFR mutated status in patients with adenocarcinoma.
  • Prior or concurrent invasive malignant disease, unless in complete remission for more than three years.
  • Significant cancer-related weight loss (≥10%)within four weeks prior to treatment start
  • Prior treatment with docetaxel-containing therapy
  • Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement
  • Paraneoplastic syndromes
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01951157


Locations
United States, New York
New York, New York, United States
Sponsors and Collaborators
PharmaMar
  More Information

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT01951157     History of Changes
Other Study ID Numbers: PM1183-B-004-13
First Submitted: September 17, 2013
First Posted: September 26, 2013
Last Update Posted: December 15, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators