ClinicalTrials.gov

History of Changes for Study: NCT02424617
A Study of BGB324 in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer
Latest version (submitted August 16, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 20, 2015 None (earliest Version on record)
2 April 30, 2015 Eligibility and Study Status
3 July 10, 2015 Contacts/Locations and Study Status
4 July 30, 2015 References and Study Status
5 February 15, 2016 Study Status
6 March 17, 2017 Contacts/Locations, Study Status, Arms and Interventions, Study Design, IPDSharing, References, Eligibility, Study Description, Sponsor/Collaborators and Study Identification
7 July 3, 2017 Contacts/Locations, Study Description and Study Status
8 October 13, 2021 Recruitment Status, Study Status, IPDSharing, Outcome Measures, Arms and Interventions, Contacts/Locations, Study Design, Study Description, Study Identification, References, Eligibility and Sponsor/Collaborators
9 August 16, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02424617
Submitted Date:  April 20, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: BGBC004
Brief Title: A Study of BGB324 in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer
Official Title: A Multi-Center Open-Label Phase I Study of BGB324 in Combination With Erlotinib in Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Recruiting
Study Start: March 2015
Primary Completion: December 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: April 9, 2015
First Submitted that
Met QC Criteria:
April 20, 2015
First Posted: April 23, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 20, 2015
Last Update Posted: April 23, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: BerGenBio ASA
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:

This is a multi-center, multi-arm open-label Phase I/2 study that will be conducted at up to 4 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) or in combination with erlotinib (Arms A-C).

The dose of erlotinib will be 150 mg daily (Arms A - C). A dose of 100 mg daily will be permitted in Arms B and C only. In Arm A, the dose of BGB324 will be escalated in a standard 3+3 fashion until an MTD of the combination is established. At this point, Arm B and Arm C will be initiated. It is intended that the BGB324 MTD dose observed in Arm A will be used in Arms B and C, but a lower dose level may be incorporated upon recommendation of the Safety Review Committee. Dose escalation beyond the Arm A MTD level is not planned for Arm B or Arm C.

Open or close this module Conditions
Conditions: Non-Small Cell Lung Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Crossover Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 66 [Anticipated]
Open or close this module Arms and Interventions
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.
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 Names:
  • 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.
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 Names:
  • 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.
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 Names:
  • Tarceva
Drug: BGB324
Study investigational product.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. History of an ischemic cardiac event including myocardial infarction
[ Time Frame: within 3 months of study entry ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
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 full dose erlotinib for treatment of NSCLC for at least six weeks with erlotinib-related toxicities being well-controlled and less than Grade 3 in severity at screening and is scheduled to continue treatment with erlotinib
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Dr. Murray Yale, MD
Telephone: 47 535 01 564
Email: murray.yule@bergenbio.com
Study Officials: Dr. Lauren Byers, MD
Principal Investigator
MD, Anderson Cancer Centre Houston, Texas
Locations: United States, Texas
Oncology Consultants
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Julio Peguero, MD 713-600-0913 jpeguero@oncologyconsultants.com
Contact:Contact: Angel Coria +1-713-600-0991 acoria@OcncologyConsultants.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services