Back to resultsAn Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
RO4929097
RO4929097
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
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 </= 4 weeks before first dose of study drug
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
cohort 1
cohort 2
Arm Description
Outcomes
Primary Outcome Measures
Tumour blood flow and tumour metabolic response rate
Secondary Outcome Measures
Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)
Tumour response according to RECIST criteria
Safety and tolerability: AEs, laboratory parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01070927
Brief Title
An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort 2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is <50.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cohort 1
Arm Type
Experimental
Arm Title
cohort 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO4929097
Intervention Description
80mg po daily, 3 days on 4 days off schedule
Intervention Type
Drug
Intervention Name(s)
RO4929097
Intervention Description
recommended phaseII dose, orally once daily, 3 days on 4 days off schedule
Primary Outcome Measure Information:
Title
Tumour blood flow and tumour metabolic response rate
Time Frame
PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)
Time Frame
pharmacokinetics: cycle 1 on days 1, 2, 4, 10, 11, 16; cycle 2 on days 1, 2, 16\npharmacodynamics: cycle 1 on days 1, 2, 4, 11, 16; cycle 2 on days 1, 16
Title
Tumour response according to RECIST criteria
Time Frame
assessments once every 2nd cycle on day 16
Title
Safety and tolerability: AEs, laboratory parameters
Time Frame
throughout study, laboratory assessments on days 1, 8 and 15 of each cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 </= 4 weeks before first dose of study drug
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer
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