ACTRN12610000312044RecruitingPhase 3
A double blind placebo controlled randomized trial to evaluate the effect of PF-804 on overall survival in patients with incurable stage IIIb/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease
CIC Clinical Trials Group0 sites720 target enrollmentStarted: April 19, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 720
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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
Investigators
Similar Trials
Not yet recruiting
Phase 3
To study the effect of cannabis capsules (medical Ganja) taken orally as compare to placebo( no active treatment) for pain relief in chronic cancer.CTRI/2022/07/044046Tata Memorial Centre Mumbai
Completed
Phase 2
A clinical trial to study the effects of a herbal drug Qurs Mufasil in patients with joint pain (Arthritis)CTRI/2009/091/000746Hamdard National Foundation,Asaf Ali Road, New Delhi150
Active, not recruiting
Not Applicable
A double-blind placebo controlled randomized 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.Incurable stage IIIB/IV non-small cell lung cancer after failure of standard therapy for advanced or metastatic disease.MedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-016509-41-ITWWCR, WORLDWIDE CLINICAL RESEARCH720
Completed
Phase 4
Study of controlled release mebeverine in irritable bowel syndrome in comparison to placebo.CTRI/2018/03/012897Department of Pharmacology40
Completed
Not Applicable
A study to assess the effects of GutGard in the management of Helicobacter pyloriCTRI/2011/08/001968ICS CO LTD100