We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 48 for:    Tarceva | Recruiting Studies | Non-small Cell Lung Cancer
Previous Study | Return to List | Next Study

A Study of BGB324 in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified March 2017 by BerGenBio ASA
Sponsor:
ClinicalTrials.gov Identifier:
NCT02424617
First Posted: April 23, 2015
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
BerGenBio ASA
  Purpose
A Phase I/2 multi-center open-label study of BGB324 in combination with erlotinib in patients with Stage IIIb or Stage IV non-small cell lung cancer. BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor which is connected with poor prognosis and acquired resistance to therapy.

Condition Intervention Phase
Non-Small Cell Lung Cancer Drug: erlotinib Drug: BGB324 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Open-Label Phase I/2 Study of BGB324 in Combination With Erlotinib in Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by BerGenBio ASA:

Primary Outcome Measures:
  • History of an ischemic cardiac event including myocardial infarction [ Time Frame: within 3 months of study entry ]

Estimated Enrollment: 66
Study Start Date: March 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
designed to determine the maximum dose of BGB324 that can be safely administered in combination with erlotinib administered at the approved oral dose level of 150 mg daily. It is anticipated that a maximum of three BGB324 dose levels will be evaluated, with up to approximately 18 patients enrolled. In the absence of unacceptable toxicity, patients will be allowed to continue receiving BGB324 in combination with erlotinib until disease progression.- (Arm completed)
Drug: erlotinib
erlotinib is used to treat non-small cell lung cancer (NSCLC), pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR).
Other Name: Tarceva
Drug: BGB324
Study investigational product.
Active Comparator: Arm B
will incorporate a Simon-like two-stage design with relaxed stopping for futility to evaluate the safety, pharmacokinetics and clinical activity of BGB324 in combination with erlotinib in patients with an activating EGFR mutation who have progressed after receiving prior erlotinib.( Open to enrolment)
Drug: erlotinib
erlotinib is used to treat non-small cell lung cancer (NSCLC), pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR).
Other Name: Tarceva
Drug: BGB324
Study investigational product.
Active Comparator: Arm C
will evaluate the safety, pharmacodynamics and clinical activity of BGB324 when administered in combination with erlotinib in patients with an activating EGFR mutation who have received at least twelve weeks of erlotinib without disease progression.(Open to enrolment)
Drug: erlotinib
erlotinib is used to treat non-small cell lung cancer (NSCLC), pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR).
Other Name: Tarceva
Drug: BGB324
Study investigational product.
Run in Arm
The primary goal of the Run-in Cohort is to establish the safety and tolerability of BGB324 administered as a single agent. Eligible patients will have either exhausted existing licensed therapies or be unsuitable for treatment with existing licensed therapies for NSCLC. BGB324 will be administered at a loading dose of 600 mg on Day 1 and Day 2 of Cycle 1, followed by 200 mg daily thereafter (Arm completed)
Drug: BGB324
Study investigational product.

Detailed Description:

This is a multi-center, multi-arm open-label Phase I/2 study that will be conducted at up to 11 clinical sites in the US.

Up to approximately 66 patients with histologically- or cytologically-confirmed Stage IIIb or Stage IV non-small cell lung cancer will receive BGB324 as a single agent (Run-in Cohort(mono therapy)) or in combination with erlotinib (Arms A, B, C).

Run-in Arm to establish the safety and tolerability of BGB324 administered as a single agent. BGB324 will be administered at a loading dose of 600 mg on Day 1 and Day 2 of Cycle 1, followed by 200 mg daily thereafter. After 6 patients have been dosed and safety established Arm A ( dose escalation arm) will be opened to confirm the BGB324 to be used in combination with erlotinib.

In Arm A the dose of BGB324 will be escalated in a standard 3+3 fashion until an MTD of the combination ( BGB324+ erlotinib) is established. The dose of BGB324 to be investigated in arm B and C will be confirmed upon recommendation of a Safety Review Committee.

Arm B and C will open in parallel and will investigate BGB324 in combination with erlotinib.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent to participate in this investigational study
  • Histological or cytological confirmation of Stage IIIb or Stage IV (unresectable) NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Age 18 years or older
  • Known EGFR mutation status
  • Has been receiving erlotinib for treatment of NSCLC with erlotinib-related toxicities well-controlled and less than Grade 3 in severity at screening
  • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to taking their first dose of BGB324. Male patients and female patients of reproductive potential must agree to practice highly effective methods of contraception (such as hormonal implants, combined oral contraceptives, injectable contraceptives, intrauterine device with hormone spirals, total sexual abstinence, vasectomy) throughout the study and for ≥3 months after the last dose of BGB324. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility, including tubal ligation, or evidence of post-menopausal status defined as any of the following:

    • Natural menopause with last menses >1 year ago
    • Radiation induced oophorectomy with last menses >1 year ago
    • Chemotherapy induced menopause with last menses >1 year ago

Exclusion Criteria:

  • Pregnant or lactating
  • Abnormal left ventricular ejection fraction (less than the lower limit of normal for a patient of that age at the treating institution or <45%)
  • Treatment with any of the following: histamine receptor two inhibitors, protocol pump inhibitors or antacids within three days or five half-lives, whichever is longer
  • History of an ischemic cardiac event including myocardial infarction within 3 months of study entry
  • NSCLC with evidence of a centrally cavitating lesion
  • Pulmonary hemorrhage or hemoptysis > 2.5 mL blood within six weeks unless cause has been addressed and is medically resolved
  • Treatment with cytotoxic chemotherapy within the preceding four weeks
  • Treatment with other non-cytotoxic agents for NSCLC in the preceding ten days or four terminal half-lives, whichever is shorter
  • Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
  • Unstable cardiac disease, including unstable angina or unstable hypertension, as defined by the need for change in medication for lack of disease control within the last three months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424617


Contacts
Contact: Dr. Murray Yale, MD 47 535 01 564 murray.yule@bergenbio.com

Locations
United States, California
Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Jorge Nieva, Dr       Jorge.Nieva@med.usc.edu   
Moores UC San Diego Cancer Center Recruiting
San Diego, California, United States, 92093-0698
Contact: Angelo Cabal, BA    858-822-7951    acabal@ucsd.edu   
Contact: Kathyrn Gold, MD       kagold@ucsd.edu   
United States, Florida
Moffit Cancer Centre Recruiting
Tampa, Florida, United States, 33612
Contact: Trajic Kristina    813-745-1480    kristina.trajic@moffit.org   
Contact: Alberto Chiappori, MD         
United States, Indiana
Horizon Oncology,1345 Unity Place Recruiting
Lafayette, Indiana, United States, 47905
Contact: Wharl Harb, MD    765-446-5112    wharb@hoizonbioadvance.com   
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Nicolle Leon    313-916-6781      
Contact: Igor Rybkin, Dr       IRYBKIN1@hfhs.org   
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Caitlon Jacoby    615-329-6805    caitlon.jacoby@scresearch.net   
Contact: Mellisa Johnson, MD       melissa.johnson@scresearch.net   
United States, Texas
Mary Crowley Cancer Research Unit Recruiting
Dallas, Texas, United States, 75230
Contact    972-566-3000      
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9105
Contact: Penny Currykosky    214-648-5107    Penny.Currykosky@UTSouthwestern.edu   
Contact: David Gerber, MD       david.gerber@UTSouthwestern.edu   
Oncology Consultants Recruiting
Houston, Texas, United States, 77030
Contact: Julio Peguero, MD    713-600-0913    jpeguero@OncologyConsultants.com   
Contact: Laura Guerra    +1-713-600-0900    research@oncologyconsultants.com   
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lauren A. Byers, MD    713-745-2982    lbyers@MDAnderson.org   
Sponsors and Collaborators
BerGenBio ASA
Chiltern International Inc.
Investigators
Principal Investigator: Dr. Lauren Byers, MD MD, Anderson Cancer Centre Houston, Texas
  More Information

Additional Information:
Responsible Party: BerGenBio ASA
ClinicalTrials.gov Identifier: NCT02424617     History of Changes
Other Study ID Numbers: BGBC004
First Submitted: April 9, 2015
First Posted: April 23, 2015
Last Update Posted: July 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Erlotinib Hydrochloride
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action