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
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: RO4929097
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cohort 1 Drug: RO4929097
80mg po daily, 3 days on 4 days off schedule
Experimental: cohort 2 Drug: RO4929097
recommended phaseII dose, orally once daily, 3 days on 4 days off schedule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070927

Locations
Netherlands
Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01070927     History of Changes
Other Study ID Numbers: NP22383, 2008-006384-37
Study First Received: February 16, 2010
Last Updated: August 4, 2014
Health Authority: Netherlands: Dutch Health Care Inspectorate

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014