Non-small Cell Lung CancerPhase 2NCT01844791
An Exploratory Study of OCZ103-OS in Combination With Standard of Care in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients
A Phase 2 study testing OCZ103-OS, Platinum and Gemcitabine in people with Non-small Cell Lung Cancer, run by Oncozyme Pharma Inc. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- OCZ103-OS, Platinum and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2012to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- OCZ103-OS, Platinum, Gemcitabine
- Keywords
- Non-small cell lung cancer, OCZ103-OS, Pentamidine bis(2-hydroxyethanesulfonate), platinum-gemcitabine based doublet first line therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCZ103-OSDrug
Also called pentamidine bis(2-hydroxyethanesulfonate
OCZ103-OS is given in combination with chemotherapy each cycle
PlatinumDrug
Platinum is given as standard chemotherapy each cycle
GemcitabineDrug
Gemcitabine is given as standard chemotherapy each cycle
| Study group | Role | What they receive |
|---|---|---|
| OCZ103-OS, Platinum, Gemcitabine | Experimental | OCZ103-OS in combination with Platinum-Gemcitabine as standard of care Receives: Drug: OCZ103-OS; Drug: Platinum; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response
To assess the effect of OCZ103-OS on overall objective response in subjects with stage IV non-small cell lung cancer.
Measured: one year four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncozyme Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ewa Kalinka-Warzocha, MD-PhD, Study director, Wojewodzki Szpital Specjalistyczny im .M. Kopernika w
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844791
- Sponsor's protocol ID
- OCZ103-206
- Status last verified
- Oct 2014
- First submitted
- 29 Apr 2013
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01844791
- Acronym / sponsor ID
- OCZ103-206
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Oncozyme Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCZ103-OS, Platinum, Gemcitabine | Experimental | Drug: OCZ103-OS, Drug: Platinum, Drug: GemcitabineOCZ103-OS in combination with Platinum-Gemcitabine as standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCZ103-OSAlso: pentamidine bis(2-hydroxyethanesulfonateOCZ103-OS is given in combination with chemotherapy each cycle | Drug | OCZ103-OS, Platinum, Gemcitabine |
| PlatinumPlatinum is given as standard chemotherapy each cycle | Drug | OCZ103-OS, Platinum, Gemcitabine |
| GemcitabineGemcitabine is given as standard chemotherapy each cycle | Drug | OCZ103-OS, Platinum, Gemcitabine |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Kalinka-Warzocha, MD-PhD study director
Wojewodzki Szpital Specjalistyczny im .M. Kopernika w
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OCZ103-OS, Platinum and Gemcitabine in people with Non-small Cell Lung Cancer, run by Oncozyme Pharma Inc. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response (time frame: one year four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.