EUCTR2007-004574-11-DE
Active, not recruiting
Not Applicable
RANDOMISED, DOUBLE-BLINDED, PLACEBO- CONTROLLED PHASE 2 STUDY OF CS-1008 IN COMBINATION WITH CARBOPLATIN/PACLITAXEL IN CHEMOTHERAPY NAÏVE SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER
Daiichi Sankyo Development Limited0 sites120 target enrollmentDecember 7, 2007
ConditionsTreatment of metastatic or unresectable non small cell lung cancer (NSCLC) with CS 1008 or placebo first in combination with carboplatin/paclitaxel then as monotherapy in the first line settingMedDRA version: 14.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Treatment of metastatic or unresectable non small cell lung cancer (NSCLC) with CS 1008 or placebo first in combination with carboplatin/paclitaxel then as monotherapy in the first line setting
- Sponsor
- Daiichi Sankyo Development Limited
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically or cytologically confirmed, stage IIIB wet or stage IV NSCLC.
- •2\. At least 18 years of age.
- •3\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\.
- •4\. Measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- •5\. Adequate organ and bone marrow function as evidenced by:
- •\- Hemoglobin \>/\= 9 g/dL;
- •\- Absolute neutrophil count \>/\= 1\.5 x 10(e \+9\)/L;
- •\- Platelet count \>/\= 100 x 10(e \+9\)/L;
- •\- Serum creatinine \< 1\.5 mg/dL or creatinine clearance \> 60 mL/min;
- •\- AST, ALT, and alkaline phosphatase \= 5\.0 x ULN if liver or bone metastasis;
Exclusion Criteria
- •1\. Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study for NSCLC.
- •2\. No recurrent NSCLC or presence of clinically significant ascites.
- •3\. Prior treatment with chemotherapy investigational medicinal products, or biological treatment for NSCLC.
- •4\. Prior radiotherapy with curative intent for NSCLC.
- •5\. Palliative radiotherapy for NSCLC within 4 weeks prior to first dose.
- •6\. Major surgery within 4 weeks prior to first dose.
- •7\. History of any of the following conditions within 6 months before study enrolment: myocardial infarction;
- •New York Heart Association (NYHA) class II or higher severe/unstable angina pectoris; coronary/peripheral
- •artery bypass graft; NYHA class III or IV congestive heart failure; cerebrovascular accident or transient
- •ischemic attack, pulmonary embolism, or other clinically significant thromboembolic event; clinically significant
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III, SUPERIORITY TRIAL TO ASSESS THE EFFICACY AND SAFETY OF ACETYL-L-CARNITINE IN COMBINATION WITH A CISPLATIN CONTAINING CHEMOTHERAPY AS FIRST LINE TREATMENT OF ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER - NDEUCTR2010-022021-15-ITIST. DI RICERCHE FARMACOLOG. M. NEGRI
Active, not recruiting
Not Applicable
DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECT OF A 4-WEEK TREATMENT WITH ORAL DOSES OF MEN15596 IN IRRITABLE BOWEL SYNDROME - NDirritable bowel syndromeMedDRA version: 9.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersEUCTR2008-000214-71-ITaboratorios Menarini S.A. - Menarini Group560
Active, not recruiting
Not Applicable
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTI-CENTRE, PHASE IIB/III STUDY OF THE EFFICACY AND SAFETY OF THREE DOSES OF SLIT ADMINISTERED AS TABLETS ONCE DAILY TO PATIENTS SUFFERING FROM GRASSES POLLEN RHINOCONJUNCTIVITISEUCTR2004-001910-15-ITSTALLERGENES
Active, not recruiting
Not Applicable
DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED PROSPECTIVE MULTI-CENTRE PHASE III TRIAL TO ASSESS THE EFFICACY AND SAFETY OF METHANTHELINIUM BROMIDE (VAGANTIN®) IN THE TREATMENT OF FOCAL PALMAR-AXILLARY HYPERHIDROSISTreatment of patients with axillary and palmar hyperhidrosisEUCTR2007-007055-13-DERIEMSER Arzneimittel AG336
Unknown
Not Applicable
A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF PIRFENIDONE IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSISPER-071-11InterMune, Inc.,44