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Carboplatin

Gemcitabine

Antimetabolites

Alkylating Agents

Gemcitabine/carboplatin will be administered as standard 21-day treatment cycles according to normal clinical practice.

* Gemcitabine will be given by 30 minute intravenous infusions on Day 1 and Day 8 of each 21-day Cycle.
* On Day 1, carboplatin (AUC5) will be given by infusion over 30-60 minutes.

* Apatorsen (OGX-427) will be administered as an intravenous infusion over 2 hours.
* Apatorsen (OGX-427) treatment will begin with a loading dose period prior to the initiation of chemotherapy. Patients will receive three loading doses of 400 mg within a 9-day period with at least 48 hours between infusions and between the last loading dose infusion and Day 1 of initiating chemotherapy. Chemotherapy must be initiated within 7 calendar days once the last loading dose infusion has been completed.
* Following the loading dose period, Apatorsen (OGX-427) will be given weekly at a dose of 400 mg by 2 hour intravenous infusions. On days when both chemotherapy and Apatorsen (OGX-427) are given, Apatorsen (OGX-427) should be given first followed by chemotherapy.

Apatorsen (OGX-427) is a second generation antisense oligonucleotide designed to bind to Hsp27 mRNA

Apatorsen (OGX-427)

Gemcitabine is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Gemcitabine is classified as an antimetabolite

Carboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent."

Peter Schmid, Prof.

This study is being carried out to see if a new drug called Apatorsen in combination with standard gemcitabine/carboplatin chemotherapy is effective in treating squamous cell lung cancer.

This study is part of a research project for collecting information about the effectiveness and safety of Apatorsen when used with gemcitabine/carboplatin chemotherapy. The main purpose of this study is to see if Apatorsen, when combined with gemcitabine/carboplatin, is an effective treatment for squamous cell lung cancer.

Recent research has found that a protein called Hsp27 can help cancer cells protect themselves against the effects of cancer treatments. Hsp27 is only found in some lung cancers but when it is present, cancer drugs might not work as well as they would without Hsp27 being present. Blocking the action of Hsp27 or removing Hsp27 from cancer cells with Apatorsen may slow down or stop the cancer growing. This study will therefore look at the relationship between the Hsp27 levels in tumour and blood and the effect of the treatment.

The development of Apatorsen is intended to provide a new treatment option for patients with cancer. Apatorsen may also make the cancer more sensitive to gemcitabine and carboplatin and so make this chemotherapy treatment more effective.

This is an open-label, multicentre, 2-arm randomised phase II trial of gemcitabine/carboplatin + Apatorsen (OGX-427) versus gemcitabine/carboplatin alone in patients with previously untreated advanced squamous cell lung cancers. Patients will be randomised (1:1) to one of the two treatment arms:

* Gemcitabine/carboplatin
* Gemcitabine/carboplatin + Apatorsen (OGX-427)

Randomisation will be stratified by the following criteria:

* Stage (IIIB versus IV versus recurrent disease)
* Performance status (0 or 1 versus 2)

Gemcitabine/carboplatin chemotherapy will be continued for 4-6 cycles unless there is evidence of unacceptable toxicity, disease progression, or if the patient requests that study treatment be discontinued or to be withdrawn from the study. If chemotherapy is discontinued prior to disease progression, patients in the combination arm should be continued on Apatorsen (OGX-427) single agent therapy until disease progression unless there is evidence of unacceptable toxicity, patient withdrawal of consent or termination of the study, whichever occurs first. All patients will be followed for disease progression. Tumour evaluations will be performed before the initiation of treatment and every 6 weeks during and after completion of chemotherapy. Once disease progression is documented, patients will enter a Survival Follow-up Period during which data will be collected every two months regarding further cancer therapy, secondary malignancy and survival status. The study will also assess the relationship between the anticipated anti-tumour activity of the treatment regimen and biological characteristics of patients' tumours at baseline.

Study of Gemcitabine/Carboplatin First-line Chemotherapy +/- Apatorsen in Advanced Squamous Cell Lung Cancers

A Phase II Randomised, Open-label Study of Gemcitabine/Carboplatin First-line Chemotherapy in Combination With or Without the Antisense Oligonucleotide Apatorsen (OGX-427) in Advanced Squamous Cell Lung Cancers

Explore potential biomarkers that may help predict response to gemcitabine/carboplatin + Apatorsen (OGX-427) compared with gemcitabine/carboplatin alone.

Estimate the clinical benefit of chemotherapy + Apatorsen (OGX-427) relative to chemotherapy alone in patients with and without high Hsp27 expression in tumour tissue and by analysing the reduction of serum Hsp27 levels during treatment.

Progression-free survival, defined as the time from the date of randomisation to the date of first documented tumour progression based on investigator assessment (using RECIST 1.1) or death from any cause, whichever occurs first.

Assess the clinical activity, as measured by response rate (RECIST 1.1), change in tumour size, disease control rate, and duration of response of gemcitabine/carboplatin + Apatorsen (OGX-427) relative to gemcitabine/carboplatin alone

Estimate the overall survival benefit of gemcitabine/carboplatin + Apatorsen (OGX-427) relative to gemcitabine/carboplatin alone

Estimate the clinical benefit of gemcitabine/carboplatin + Apatorsen (OGX-427) relative to gemcitabine/carboplatin alone, as measured by investigator-assessed PFS rate at 12 and 24 weeks

Evaluate drug exposure of gemcitabine/carboplatin + Apatorsen (OGX-427). Exposure is defined as average gemcitabine/carboplatin + Apatorsen (OGX-427) dose per week over whole treatment period.

Gemcitabine/carboplatin chemotherapy will be continued for 6 cycles (each cycle is 21 days) unless there is evidence of unacceptable toxicity, disease progression, or if the patient requests that study treatment be discontinued or to be withdrawn from the study. If chemotherapy is discontinued prior to disease progression, patients in the combination arm should be continued on Apatorsen (OGX-427) single agent therapy until disease progression unless there is evidence of unacceptable toxicity, patient withdrawal of consent or termination of the study, whichever occurs first.

Compare the differences in health-related quality of life (HRQL) and symptoms for patients by treatment assignment

Establish the safety and tolerability of gemcitabine/carboplatin + apatorsen (OGX-427) relative to gemcitabine/carboplatin alone.

This will include:

* Incidence of serious adverse events
* Incidence of grade 3 or higher adverse events (CTCAE, version 4.0)
* Incidence of all adverse events of all grades
* Incidence of infusion reactions and infusion-related adverse events
* Adverse events leading to discontinuation of the study medication
* Incidence of Grade 3 and 4 clinical laboratory results following study drug administration (CTCAE, version 4.0.3)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Gemcitabine/Carboplatin First-line Chemotherapy +/- Apatorsen in Advanced Squamous Cell Lung Cancers	NCT02423590	Squamous Cell L...	Apatorsen (OGX-... Gemcitabine Carboplatin	18 Years -	Queen Mary University of London
Study of Gemcitabine/Carboplatin First-line Chemotherapy +/- Apatorsen in Advanced Squamous Cell Lung Cancers	NCT02423590	Squamous Cell L...	Apatorsen (OGX-... Gemcitabine Carboplatin	18 Years -	Queen Mary University of London

Spots Global Cancer Trial Database for apatorsen

Every month we try and update this database with for apatorsen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for apatorsen

Every month we try and update this database with for apatorsen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for apatorsen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.