An Exploratory Study on Anti-tumour Activity of Orally Administered RO4929097, a Gamma-secretase Inhibitor, as a Single Agent in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer (NSCLC).
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
An Exploratory Study on Anti-tumour Activity of Orally Administered RO4929097, a Gamma-secretase Inhibitor, as a Single Agent in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer (NSCLC).
Inclusion Criteria:
- adult patients, >/= 18 years of age
- stage IIIB/IV recurrent or refractory non-small cell lung cancer
- at most 2 lines of prior therapy in the metastatic setting (first line: platinum
containing regimen and bevacizumab; second line: EGFR-targeted therapy)
- ECOG performance status 0-2
- adequate liver, renal and bone marrow function
Exclusion Criteria:
- prior chemotherapy or radiotherapy
- history of other malignancy within the past 2 years, except for basal cell skin
carcinoma or in situ cervical carcinoma
- history of CNS metastases or leptomeningeal metastases, except for clinically stable
disease
- serious cardiovascular illness
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumour blood flow and tumour metabolic response rate
Outcome Time Frame:
PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Netherlands: Dutch Health Care Inspectorate
Study ID:
NP22383
NCT ID:
NCT01070927
Start Date:
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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