An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01070927
First received: February 16, 2010
Last updated: August 4, 2014
Last verified: August 2014

February 16, 2010
August 4, 2014
January 2010
August 2010   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01070927 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Tumour response according to RECIST criteria [ Time Frame: assessments once every 2nd cycle on day 16 ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: throughout study, laboratory assessments on days 1, 8 and 15 of each cycle ] [ Designated as safety issue: No ]
  • 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 pharmacodynamics: cycle 1 on days 1, 2, 4, 11, 16; cycle 2 on days 1, 16 ] [ Designated as safety issue: No ]
  • Tumour response according to RECIST criteria [ Time Frame: assessments once every 2nd cycle on day 16 ] [ Designated as safety issue: No ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: throughout study, laboratory assessments on days 1, 8 and 15 of each cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer
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).

This study will evaluate the anti-tumour activity, safety and tolerability of RO 4929097 as monotherapy in patients with recurrent or refractory non-small cell l ung 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. Anticip ated time on study treatment is until disease progression or unacceptable toxici ty. Target sample size is <50.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: RO4929097
    80mg po daily, 3 days on 4 days off schedule
  • Drug: RO4929097
    recommended phaseII dose, orally once daily, 3 days on 4 days off schedule
  • Experimental: cohort 1
    Intervention: Drug: RO4929097
  • Experimental: cohort 2
    Intervention: Drug: RO4929097
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01070927
NP22383, 2008-006384-37
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP