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

This study has suspended participant recruitment.
(Enrollment suspended due to PK liabilities, and not related to safety)
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01070927
First received: February 16, 2010
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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 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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 ]

Estimated Enrollment: 20
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
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: Disclosures Group, 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: November 15, 2011
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 May 23, 2013