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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070927
• Other study ID #: NP22383
• Secondary ID: 2008-006384-37
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2010
• Last updated: November 1, 2016
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• RO4929097
80mg po daily, 3 days on 4 days off schedule
• RO4929097
recommended phaseII dose, orally once daily, 3 days on 4 days off schedule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour blood flow and tumour metabolic response rate		PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)	No
Secondary	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	No
Secondary	Tumour response according to RECIST criteria		assessments once every 2nd cycle on day 16	No
Secondary	Safety and tolerability: AEs, laboratory parameters		throughout study, laboratory assessments on days 1, 8 and 15 of each cycle	No