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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

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

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

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.

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

- 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

- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response

Outcome Description:

To assess the effect of OCZ103-OS on overall objective response in subjects with stage IV non-small cell lung cancer.

Outcome Time Frame:

one year four months

Safety Issue:


Principal Investigator

Ewa Kalinka-Warzocha, MD-PhD

Investigator Role:

Study Director

Investigator Affiliation:

Wojewodzki Szpital Specjalistyczny im .M. Kopernika w


Poland: Office for Registration of Medicinal Products, Medical devices, and Biological Products

Study ID:




Start Date:

September 2012

Completion Date:

January 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • OCZ103-OS
  • Pentamidine bis(2-hydroxyethanesulfonate)
  • platinum-gemcitabine based doublet first line therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms