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

NCT01070927 | Completed Phase 2

• 2 other identifiers: NP223832008-006384-37
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

cohort 1

EXPERIMENTAL

Drug: RO4929097

cohort 2

EXPERIMENTAL

Drug: RO4929097

Interventions

RO4929097 DRUG

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

cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Amsterdam, 1007 MB, Netherlands

Location

MeSH Terms

Interventions

2,2-dimethyl-N-(6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-N'-(2,2,3,3,3-pentafluoropropyl)malonamide

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 18, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)