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Completed

NCT Number: NCT01070927

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

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.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amsterdam, 1007 MB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO4929097

Drug

80mg po daily, 3 days on 4 days off schedule

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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).

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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