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

NCT01844791 | Completed Phase 2 DMC

• 1 other identifier: OCZ103-206
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; OCZ103-OS; Pentamidine bis(2-hydroxyethanesulfonate); platinum-gemcitabine based doublet first line therapy

Outcome Measures

Primary Outcomes (1)

• Overall Response

  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

Study Arms (1)

OCZ103-OS, Platinum, Gemcitabine

EXPERIMENTAL

OCZ103-OS in combination with Platinum-Gemcitabine as standard of care

Drug: OCZ103-OS; Drug: Platinum; Drug: Gemcitabine

Interventions

OCZ103-OS DRUG

OCZ103-OS is given in combination with chemotherapy each cycle

Also known as: pentamidine bis(2-hydroxyethanesulfonate

OCZ103-OS, Platinum, Gemcitabine

Platinum DRUG

Platinum is given as standard chemotherapy each cycle

OCZ103-OS, Platinum, Gemcitabine

Gemcitabine DRUG

Gemcitabine is given as standard chemotherapy each cycle

OCZ103-OS, Platinum, Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Informed Consent;
• Males or females;
• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Oncozyme Pharma Inc.: lead

Study Sites (1)

Ewa Kalinka-Warzocha

Lodz, 93-513, Poland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Platinum; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ewa Kalinka-Warzocha, MD-PhD

  Wojewodzki Szpital Specjalistyczny im .M. Kopernika w

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: September 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

PL (1)