An Exploratory Study of OCZ103-OS in Combination With Standard of Care in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients

October 20, 2014 updated by: Oncozyme Pharma Inc.

A Phase IIa Exploratory Study of OCZ103-OS in Combination With Platinum-Gemcitabine Based Doublet First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients

The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS in combination with Platinum-Gemcitabine based doublet first line therapy in stage IV non-small cell lung cancer (NSCLC) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single arm, open label study to investigate the safety and efficacy of the use of OCZ103-OS in combination with Platinum-gemcitabine base doublet first line therapy in stage IV non-small cell lung cancer (NSCLC) patients.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 93-513
        • Ewa Kalinka-Warzocha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written Informed Consent;
  • Males or females;
  • 18-75 years;
  • Histologically or cytologically confirmed stage IV NSCLC patients that are eligible to platinum-gemcitabine based doublet therapy (M1a and M1b, seventh edition descriptor of the Revised International System for Staging Lung Cancer, adopted by the AJCC.) Patients with a prior diagnosis of stage IIIa or IIIb NSCLC who have progressed to stage IV are also eligible;
  • ECOG performance 0 or 1;
  • One or more tumor lesions measurable by RECIST criteria version 1.1, on CT scan or MRI;
  • Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the selected measurable lesions are outside the original radiation therapy port unless there has been demonstrated progression in the lesion. Radiation therapy must have been completed > 4 weeks prior to study entry;
  • Palliative radiotherapy must have been completed > 2 weeks prior to study entry. Concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed;
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Any prior systemic therapy for recurrent or metastatic NSCLC, except prior neoadjuvant or adjuvant systemic chemotherapy for NSCLC if administered at least 6 months prior to enrolment;
  • Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval > 450 msec for males or > 470 msec for females or uncontrolled intercurrent illness, e.g. unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia < 50 bpm; a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome);
  • Systolic Blood Pressure < 100 mmHg (if deemed clinically significant by the treating physician);
  • Uncontrolled diabetes. Patients with well controlled diabetes, with a HbA1C of less than 7%, on stable hypoglycaemic therapy and diet, are eligible;
  • Clinically significant renal impairment or chronic pancreatitis;
  • History of clinically significant hypoglycemia, with fasting blood glucose < 3 mmol/L;
  • Inadequate baseline organ function as shown by following laboratory values:
  • Hemoglobin < 100 g/L
  • Absolute neutrophil count <1.5 x 10e9/L
  • Platelet count < 100 x 10e9/L
  • Total bilirubin > 1.5 x ULN
  • AST and ALT > 2.5 x ULN or > 5 ULN in the presence of liver metastases
  • Serum creatinine > 1.5 x ULN or calculated creatinine clearance < 60 ml/min
  • To be dependent of oxygen treatment;
  • Active infections requiring antibiotics;
  • A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study;
  • Pregnancy or breastfeeding. All women of child-bearing potential must have a negative pregnancy test prior to first receiving protocol therapy;
  • Active alcohol or drug abuse;
  • Known or suspected allergy/hypersensitivity to any agent given in the course of this trial;
  • Any co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complication or reduces the probability of assessing clinical effect;
  • Other malignancies diagnosed within the last 5 years with the exception of Basal Cell Carcinoma of the skin;
  • Patients unable to comply with the study protocol and follow-up schedule for any psychological, familial, sociological or geographical reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCZ103-OS, Platinum, Gemcitabine
OCZ103-OS in combination with Platinum-Gemcitabine as standard of care
Drug: OCZ103-OS
OCZ103-OS is given in combination with chemotherapy each cycle
Other Names:
  • pentamidine bis(2-hydroxyethanesulfonate
Drug: Platinum
Platinum is given as standard chemotherapy each cycle
Drug: Gemcitabine
Gemcitabine is given as standard chemotherapy each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response
Time Frame: one year four months
To assess the effect of OCZ103-OS on overall objective response in subjects with stage IV non-small cell lung cancer.
one year four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncozyme Pharma Inc.

Investigators

  • Study Director: Ewa Kalinka-Warzocha, MD-PhD, Wojewodzki Szpital Specjalistyczny im .M. Kopernika w

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCZ103-206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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