|
Main
|
|
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:
|
EUCTR |
|
Last refreshed on:
|
9 October 2012 |
|
Main ID: |
EUCTR2008-001736-12-ES |
|
Date of registration:
|
01/08/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
|
|
Scientific title:
|
Estudio aleatorizado, doble ciego para determinar el efecto de dos pautas posológicas de R1507 o placebo, ambos en combinación con erlotinib (Tarceva®), sobre la supervivencia libre de progresión en pacientes con cáncer de pulmón no microcítico avanzado que haya progresado de la enfermedad tras haber recibido primera o segunda línea de quimioterapia..
A Randomized, double blind study to determine the effect of two dose schedules of
R1507 or placebo, both in combination with erlotinib (Tarceva®), on progression-free
survival in patients with advanced non-small cell lung cancer with disease progression after first or second line chemotherapy -
|
|
Date of first enrolment:
|
17/10/2008 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001736-12 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Belgium
|
France
|
Germany
|
Ireland
|
Italy
|
Spain
|
United Kingdom
| |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Male and female patients, age ?18 years
2. Able to comply with the protocol
3. Patients must be able to take oral medication
4. Histologically documented inoperable, locally advanced or metastatic (stage IIIB and stage IV) NSCLC. (NOTE: Sputum cytology alone is not acceptable). Tumors with
mixed histology should be categorized according to the predominant cell type
5. Prior Treatment: Failed at least one, but no more than two standard chemotherapy regimens
6. Patients who have received maintenance chemotherapy between initial course of therapy (first line) and study entry may enter on the study provided they have not been treated with an agent that targets EGFR or IGF-1R
7. Formalin fixed paraffin embedded tumor tissue samples from initial or subsequent diagnosis representative of the disease must be available for shipment to Roche prior to randomization
8. Measurable disease according to RECIST
9. ECOG performance status 0-2
10. Life expectancy > 12 weeks
11. Adequate hematological function : ANC ?1.5 x 10 exp9/L; platelets ?100 x 10 exp9/L, Hb ?9 g/dL
12. INR ?1.5 and PTT ?1.5 x ULN unless receiving anticoagulant therapy
13. Adequate liver function: Serum bilirubin ?1.5 x ULN; transaminases ?2.5 x ULN (in case of liver metastases <5 x ULN)
14. Adequate renal function: Serum creatinine ? 1.5 X ULN
15. Serum calcium ? 1.1 X ULN
16. HbA1c ? 7%
17. Negative pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause
18. Signed informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients must have had a head CT/MRI to evaluate for CNS metastasis within 28 days prior to enrollment. Patients with active CNS lesions are excluded. Patients with
radiographically stable, asymptomatic previously irradiated lesions are eligible provided patients is ? 4 weeks beyond completing cranial irradiation and ? 3 weeks off corticosteroid therapy
2. Prior treatment with an investigational or commercial agent that acts via IGF-1R inhibition
3. Prior treatment with an agent that acts via EGFR targeting
4. Administration of any anti-cancer therapies other than those administered in this study during protocol treatment
5. Administration of high doses of systemic corticosteroids. High dose is considered as > 20 mg of dexamethasone a day (or equivalent) for > 7 consecutive days.
Dexamethasone may induce CYP3A4 activity. CYP3A4 inhibitors and inducers may influence the plasma level of erlotinib
6. Prior irradiation: 1) Radiotherapy given within the last 4 weeks prior to first dose of study treatment. 2) Palliative radiotherapy for bone lesions outside the thoracic region within 2 weeks prior to the first dose of study treatment
7. Prior Surgery: Surgery (including open biopsy) or significant traumatic injury within the last 2 weeks prior to first dose of study treatment or anticipation of the need for
major surgery during study treatment
8. Patients must have recovered from any toxic effects of previously administered therapies and must be randomly assigned to study treatment at least 21 days after
chemotherapy (14 days after treatment with vinca alkaloids or gemcitabine)
9. Lactating women
10. Fertile men or women of childbearing potential not using effective methods to prevent pregnancy
11. Other active cancer requiring treatment
12. Known hypersensitivity to any of the study drugs or their excipients
13. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (? 6 months before randomization), myocardial infarction (? 6 months before randomization), unstable angina, NYHA ? grade 2 CHF, arrhythmia requiring medication, hepatic, renal or metabolic disease (including uncontrolled diabetes
mellitus), metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the
use of an investigational drug or puts the patient at high risk for treatment-related complications
14. History of allogeneic bone marrow transplantation or organ transplantation
15. Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended)
16. No dysphagia or active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption; no lack of integrity of the gastrointestinal tract (e.g. as significant surgical resection of the stomach or small bowel). Patients
unable to swallow intact tablets must be able to swallow tablets dissolved in water
17. Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Cancer de pulmón de células no microcíticas.
To investigate in a randomized fashion if the addition of targeted IGF-1R blockade with R1507 has additional clinical benefit when combined with erlotinib in patients with advanced NSCLC who have failed at least one, but no more than two standard chemotherapy regimens.
MedDRA version: 9.1
Level: LLT
Classification code 10029521
Term: Non-small cell lung cancer stage IIIB
MedDRA version: 9.1
Level: LLT
Classification code 10029522
Term: Non-small cell lung cancer stage IV
|
|
Intervention(s)
|
Product Name: huMAb IGF-1R
Product Code: RO4858696
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: not yet defined
Current Sponsor code: RO4858696 other code R1507
Other descriptive name: huMAb IGF-1R
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
|
|
Primary Outcome(s)
|
|
Main Objective: To define the proportion of patients with PFS at 12 weeks with the combination of R1507 and erlotinib or a corresponding placebo and erlotinib in patients with advanced Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) who have failed at least one standard chemotherapy regimen.
|
|
Primary end point(s): Progression-free survival at 12 weeks. PFS is defined as the time from start of treatment to first date of documented disease progression or death. This is a dichotomous endpoint, with patients categorized as alive and progression-free at 12 weeks or in progression or dead by 12 weeks.
|
Secondary Objective: - Define the effect of adding R1507 to erlotinib on progression-free survival, overall survival, objective response rate, time to response, time to progressive disease and
duration of response.
- Define population PK of R1507 in combination with erlotinib.
- Evaluate the safety profile of the combination of R1507 and erlotinib.
- Explore the changes in pharmacodynamic markers in responders and non-responders.
- Explore candidate biomarkers related to drug mechanism of action.
- To explore two doses and schedules of R1507 combined with
erlotinib in this setting.
|
|
Secondary ID(s)
|
|
2008-001736-12-BE
|
|
NO21160
|
|
Source(s) of Monetary Support
|
|
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|