Trial record 4 of 13 for:    clovis oncology

A Study to Assess the Efficacy of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With FGFR1-driven Lung Cancer

This study is not yet open for participant recruitment.
Verified April 2014 by Clovis Oncology, Inc.
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT02109016
First received: April 7, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

The purpose of this study is to determine whether lucitanib is effective in the treatment of patients with FGFR1 amplified squamous non-small cell lung cancer.


Condition Intervention Phase
Squamous NSCLC
Squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
Stage IV Lung Cancer
Lung Cancer
Metastatic Lung Cancer
Drug: Lucitanib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label, Phase II Study to Assess the Efficacy of the Dual VEGFR-FGFR Tyrosine Kinase Inhibitor, Lucitanib, Given Orally as a Single Agent to Patients With FGFR1-driven Lung Cancer

Resource links provided by NLM:


Further study details as provided by Clovis Oncology, Inc.:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Screening, every 8 weeks; up to 2 years ] [ Designated as safety issue: No ]
    Proportion of patients in whom a confirmed Complete Response (CR) or a confirmed Partial Response (PR), as best overall response according to RECIST criteria, is observed.


Secondary Outcome Measures:
  • Clinical Benefit Rate (CBR) [ Time Frame: Screening, every 8 weeks; up to 2 years ] [ Designated as safety issue: No ]
    Proportion of patients in whom a confirmed CR or confirmed PR or a prolonged Stable Disease (SD) (≥ 6 months), as best overall response according to RECIST, is observed

  • Progression-Free Survival (PFS) [ Time Frame: Screening, every 8 weeks; up to 2 years ] [ Designated as safety issue: No ]
    Time from the date of first drug intake until the date of progression or death for any cause

  • Duration of response (DOR) [ Time Frame: Screening, every 8 weeks; up to 2 years ] [ Designated as safety issue: No ]
    For responders (i.e. patients with best overall response CR or PR), the interval from the time of first documentation of response to the date of progression or death for any cause

  • Duration of clinical benefit [ Time Frame: Screening, every 8 weeks; up to 2 years ] [ Designated as safety issue: No ]
    For responders and patients with SD as best overall response, time from the first drug intake until the date of progression or death for any cause

  • Overall Survival (OS) [ Time Frame: Continuously; up to 2 years ] [ Designated as safety issue: No ]
    From the date of first drug intake to the date of death for any cause

  • Tumour growth kinetics [ Time Frame: Screening, every 8 weeks; up to 2 years ] [ Designated as safety issue: No ]

    Will be evaluated using the following criteria:

    • The tumour size defined as the sum of the largest diameters of target lesions
    • The tumour volume
    • The Tumour Growth rate defined as an increase in tumour volume during 1 month

  • Incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications [ Time Frame: Continuously; up to 2 years ] [ Designated as safety issue: Yes ]
  • PK parameters of Lucitanib [ Time Frame: Cycle 1 Day 14 and 28, Cycle 2 Day 56, Cycle 3 Day 84 ] [ Designated as safety issue: No ]
  • Pharmacogenomic approach of inter-patients variation in gene encoding ADME involved proteins [ Time Frame: Cycle 1 Day 1 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (PD) [ Time Frame: Cycle 1 Day 1 ] [ Designated as safety issue: No ]
    Soluble growth factors and other biomarkers, including circulating tumour DNA


Estimated Enrollment: 40
Study Start Date: April 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lucitanib
Lucitanib given orally once daily on a continuous schedule. Starting dose 15 mg/day
Drug: Lucitanib

Lucitanib given orally to all patients. once daily (q.d.), on a continuous schedule over 28-day cycles, in fasting conditions (at least 2 hours prior and 2 hours after any meal), until progressive disease or unacceptable toxicity.

Starting dose is 15 mg/day and can be reduced at 2.5 mg steps till 7.5 mg/day based on individual tolerability.


Detailed Description:

Lucitanib is an oral inhibitor of the tyrosine kinase activity of FGFR 1/2 and VEGFR 1-3. Lucitanib has demonstrated potent antitumour and antiangiogenic activity in several preclinical models of cancer, including a human lung cancer model (H1581) which harbors FGFR1 amplification.

The first in human trial of lucitanib demonstrated that 15 mg of lucitanib given daily, can provide durable clinical responses in cancer patients with alterations of the FGF pathway. Based on these results, lucitanib is being studied in FGFR1 amplified squamous non-small cell lung cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed stage IV squamous NSCLC
  • FGFR1-amplification determined on the most recent archive sample available or on a newly performed biopsy
  • Availability of a tissue sample suitable for the central confirmation by FISH of FGFR1 amplification
  • Eastern Cooperative Oncology Group (ECOG) of 0 or 1
  • Measurable disease per RECIST 1.1
  • At least one prior treatment line in the advanced-metastatic setting
  • Ability to take oral medication

Exclusion Criteria:

  • Symptomatic and/or untreated central nervous system metastases
  • Presence of another active cancer
  • Biologic therapy, chemotherapy, radiation, or surgery within 4 weeks of the first dose of Lucitanib
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02109016

Contacts
Contact: Clovis Oncology Clinical Trial Information clinicaltrialinfo@clovisoncology.com

Sponsors and Collaborators
Clovis Oncology, Inc.
Investigators
Study Director: Jason B Litten, MD Clovis Oncology, Inc.
  More Information

No publications provided

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02109016     History of Changes
Other Study ID Numbers: E-3810-II-02
Study First Received: April 7, 2014
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration
France: Ministry of Health
Germany: Ministry of Health
Italy: Ministry of Health
Spain: Ministry of Health

Keywords provided by Clovis Oncology, Inc.:
FGFR-1 amplification
Tyrosine kinase inhibitor
VEGFR inhibitor
FGFR inhibitor
VEGRF-FGFR inhibitor

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 April 17, 2014