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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01070927

Enrollment

Registered

2010-02-18

Start date

2010-01-31

Completion date

2010-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Squamous Non-Small Cell Lung Cancer

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.

Interventions

DRUGRO4929097

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Tumour blood flow and tumour metabolic response rate	PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)

Secondary

Measure	Time frame
Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)	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
Tumour response according to RECIST criteria	assessments once every 2nd cycle on day 16
Safety and tolerability: AEs, laboratory parameters	throughout study, laboratory assessments on days 1, 8 and 15 of each cycle

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026