A Double Blind Placebo Controlled Randomised Trial of PF-804 in Patients with Incurable Stage IIIB / IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease

Phase 3

Recruiting

• Conditions: ung Cancer; Lung Cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12610000312044
• Lead Sponsor: CIC Clinical Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

Histologically confirmed diagnosis of non-small cell carcinoma of the lung.
Patients must have evidence of disease, but measurable disease is not mandatory
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
Adequate renal and hepatic functions
Patients must have recovered from any toxic effects and at least 21 days must have elapsed from the
last dose and prior to randomization
Patients < 70 years Must have received 1-2 prior chemotherapy regimens
Patients > 70 years May have received 1 or 2 prior single agent chemotherapy regimens for their disease,
Adjuvant Chemotherapy: Patients may ALSO have had prior adjuvant therapy for completely
resected disease, providing completed at least 12 months prior to randomization.
Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy: Patients may only be enrolled after failure of prior gefitinib or erlotinib for advanced or metastatic disease
Radiation: Patients may have had prior radiation therapy provided that a minimum of 14 days has elapsed between the end of radiotherapy and randomization onto the study
Previous Surgery: Previous surgery is permitted provided that wound healing has occurred and at least 14 days have elapsed
Patient able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires.
Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements
Patients must be accessible for treatment and follow-up.
protocol treatment is to begin within 2 working days of patient randomization.

Exclusion Criteria

Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
Patients who have experienced untreated and/or uncontrolled cardiovascular conditions Patients with a significant cardiac history, even if controlled, should have a left ventricular ejection fraction (LVEF) > 50%.
Patients with untreated brain or meningeal metastases are not eligible (Computerised Tomography (CT) scans are not required to rule this out unless there is a clinical suspicion of Central Nervous System (CNS) disease).
Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which
would not permit the patient to be managed according to the protocol
Mean QTc (a measure of the time between the start of the Q wave and the end of the T wave) with Bazetts correction > 470msec in screening electrocardiogram (ECG) or history of familial long QT syndrome.
Drugs that are highly dependent on Cytochrome P450 2D6 (CYP2D6) for metabolism are prohibited
Pregnancy or inadequate contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare overall survival between the two arms. Patients are assessed for survival with a clinical examination monthly during treatment,4 weeks after the end of treatment, and then every 4 weeks after completion of treatment.[After 640 deaths have occurred on study]