Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 August 2017 |
Main ID: |
EUCTR2010-018945-72-BE |
Date of registration:
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19/07/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study of RO5083945 in combination with chemotherapy versus chemotherapy alone in patients with advanced or recurrent non-small cell lung cancer
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Scientific title:
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A randomized, multicenter, open-label phase Ib/II study of RO5083945 in combination with cisplatin and gemcitabine/pemetrexed versus cisplatin and gemcitabine/pemetrexed in patients with advanced or recurrent non small cell lung cancer who have not received prior chemotherapy |
Date of first enrolment:
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26/08/2010 |
Target sample size:
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160 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018945-72 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: stratified
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Germany
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United Kingdom
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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41616881111 |
Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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41616881111 |
Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: - adult patients, >/=18 years of age
- advanced, metastatic or recurrent non-small cell lung cancer
- at least 1 measurable disease lesion as per RECIST criteria
- confirmed presence of EGFR in tumor tissue
- ECOG performance status 0-1
- adequate hematological, renal and liver function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria: - prior chemotherapy or treatment with another systemic anti-cancer agent
- radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief
- history or clinical evidence of CNS metastases
- recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg)
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Locally advanced (stage IIIb), metastatic (IV) or recurrent, non-small cell lung cancer who have not received prior chemotherapy MedDRA version: 14.1
Level: LLT
Classification code 10025077
Term: Lung carcinoma stage IV
System Organ Class: 100000004864
MedDRA version: 14.1
Level: LLT
Classification code 10025076
Term: Lung carcinoma stage III
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: GA201 Product Code: RO5083945/F02 Pharmaceutical Form: Solution for infusion CAS Number: 959963-46-3 Current Sponsor code: RO5083945 Other descriptive name: huMab (GA201) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-
Product Name: GA201 Product Code: RO5083945/F03 Pharmaceutical Form: Solution for infusion CAS Number: 959963-46-3 Current Sponsor code: RO5083945 Other descriptive name: huMab (GA201) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
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Primary Outcome(s)
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Secondary Objective: Overall survival, event driven, assessed at end of study event driven
Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), tumor assessments every 6 weeks
Duration of response tumor assessments every 6 weeks
Overall response rate (ORR) according to RECIST criteria tumor assessments every 6 weeks
Pharmacokinetics of RO5083945 in combination with cisplatin and gemcitabine/pemetrexed, multiple sampling cycles 1-6
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Main Objective: To describe by histology group the adverse event profile, pharmacokinetics (PK) and recommended dose of RO5083945 in combination with cisplatin and gemcitabine/pemetrexed
To demonstrate evidence of superior activity of RO5083945 added to cisplatin and gemcitabine/pemetrexed versus chemotherapy alone in terms of PFS
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Primary end point(s): Progession free survival, according to RECIST criteria by CT/MRI
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Timepoint(s) of evaluation of this end point: Every 6 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Every 6 weeks
OS event driven, assessed at end of study (23 months)
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Secondary end point(s): - Pharmacokinetics of RO5083945 in combination with of cisplatin, gemcitabine/pemetrexed
- Overall response rate (ORR) according to RECIST criteria by CT/MRI
- Duration of response according to RECIST criteria by CT/MRI
- Clinical benefit according to RECIST criteria by CT/MRI
- Overall survival
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Secondary ID(s)
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BP22349
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NCT01185447
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2010-018945-72-DE
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Source(s) of Monetary Support
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F.Hoffmann-La Roche Ltd
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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