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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01070927
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: RO4929097 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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).
Study Start Date : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Tumour response according to RECIST criteria [ Time Frame: assessments once every 2nd cycle on day 16 ]
  3. Safety and tolerability: AEs, laboratory parameters [ Time Frame: throughout study, laboratory assessments on days 1, 8 and 15 of each cycle ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01070927

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Amsterdam, Netherlands, 1007 MB
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT01070927    
Other Study ID Numbers: NP22383
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms