History of Changes for Study: NCT02922777
Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.
Latest version (submitted June 28, 2022) on
  • 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 October 2, 2016 None (earliest Version on record)
2 November 22, 2016 Recruitment Status, Study Status, Contacts/Locations and Eligibility
3 May 9, 2018 Study Status
4 December 7, 2018 Study Status
5 September 23, 2019 Study Status
6 June 5, 2020 Study Status
7 March 18, 2021 Study Status
8 March 22, 2022 Recruitment Status, Sponsor/Collaborators, Study Status, Contacts/Locations and Study Design
9 June 28, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02922777
Submitted Date:  October 2, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: STU 052015-077
Brief Title: Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.
Official Title: Phase 1 Trial of Dose Escalated BGB324 in Combination With Docetaxel for Previously Treated Advanced Non-small Cell Lung Cancer (NSCLC)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2016
Overall Status: Not yet recruiting
Study Start: November 2016
Primary Completion: November 2018 [Anticipated]
Study Completion: November 2019 [Anticipated]
First Submitted: May 19, 2016
First Submitted that
Met QC Criteria:
October 2, 2016
First Posted: October 4, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 2, 2016
Last Update Posted: October 4, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Texas Southwestern Medical Center
Responsible Party: Sponsor
Collaborators: Texas Tech University Health Sciences Center
BerGenBio ASA
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: This study is being done to evaluate the safety of the investigational study drug, BGB324 when administered in combination with docetaxel, and to establish the maximum tolerated dose.
Detailed Description:

Lung cancer remains the leading cause of cancer-related deaths worldwide with an estimated incidence of 1.6 million cases resulting in 1.4 million deaths in annually. Non-small-cell lung cancer (NSCLC) represents 80-85% of cases, and adenocarcinoma is the most common histology.2 The majority of NSCLC patients present with advanced or metastatic disease that is not amenable to surgical resection. Platinum-based combination chemotherapy has reached a therapeutic plateau with a median overall survival (OS) of 7.4 to 9.9 months.

BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor that is over-expressed in many metastatic solid tumors and has been identified as a marker of a poor prognosis in patients with non-small cell lung cancer (NSCLC).

Open or close this module Conditions
Conditions: Non-Small Cell Lung Carcinoma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BGB324 in combination with docetaxel
The dose of docetaxel will be 75 mg/m2 given IV every 21 days. The dose of BGB324 will be escalated in a standard 3+3 fashion until a maximum tolerated dose is determined.
Drug: BGB324
75 mg/m2 every 21 days
Drug: Docetaxel
75 mg/m2 given IV every 21 days
Other Names:
  • Taxotere
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Determine the maximum tolerated dose of BGB324 in combination with docetaxel
[ Time Frame: 42 days or 2 cycles of 21 days ]

Determine and recommended the Phase 2 dose of BGB324 administered with the standard dose of docetaxel in patients in NSCLC by pharmacodynamics and pharmacokinetic assessments.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No

Inclusion Criteria:

A patient is eligible for the study if the following criteria are met:

  1. Provision of written informed consent to participate in this investigational study
  2. Histologically or cytologically confirmed advanced (stage 4, according to the American Joint Committee on Cancer [AJCC] Staging manual) NSCLC
  3. Up to three previous lines of therapy, of which one must have been a platinum-based doublet therapy and no more than two were cytotoxic chemotherapy.
  4. Radiographic disease recurrence or progression during or after the last line of chemotherapy
  5. Patients with known activating EGFR mutations or ALK rearrangements should have progressed after appropriate targeted treatment in addition to progressing during or after platinum-based doublet chemotherapy
  6. European Cooperative Oncology Group (ECOG) performance status 0 or 1
  7. Age 18 years or older
  8. Measurable or evaluable disease according to RECIST v1.1
  9. Previously treated brain metastases (surgery and/or radiation therapy) are eligible, provided that patients are asymptomatic and not requiring corticosteroids
  10. The following minimum intervals are required between prior treatment and initiation of study therapy:

    Cytotoxic chemotherapy: 3 weeks Molecularly targeted therapy or immunotherapy: 2 weeks Conventional fractionated radiation therapy: 2 weeks Stereotactic radiation therapy: 1 week Major surgery: 3 weeks

  11. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1500 cells/µL; hemoglobin ≥ 9 g/dL; platelets ≥ 100,000/µL
  12. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation)
  13. Adequate hepatic function: total bilirubin ≤ upper limit of normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN, aspartate aminotransferase [AST] ≤ 1.5 x ULN). ALT and AST ≤ 5x ULN if documented liver metastases
  14. Previous treatment-associated toxicities resolved to CTCAE grade ≤2 (except alopecia)
  15. Adequate archival tissue (10-15 slides, or 5 slides with 3 sections per slide) for biomarker analysis
  16. 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

A patient is excluded from the study if any of the following criteria are met:

  1. Pregnant or lactating
  2. Abnormal left ventricular ejection fraction on echocardiography (less than the lower limit of normal for a patient of that age at the treating institution or <45%)
  3. History of an ischemic cardiac event including myocardial infarction within 3 months of study entry
  4. NSCLC with evidence of a centrally cavitating lesion
  5. Peripheral neuropathy NCI CTCAE ≥Grade 2 at baseline
  6. Pulmonary hemorrhage or hemoptysis > 2.5 mL blood within 6 weeks (or within 2 weeks if source definitively treated [eg, radiation therapy or bronchoscopic procedure])
  7. Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
  8. 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
  9. History or presence of sustained bradycardia (less than or equal to 60 BPM) or history of symptomatic bradycardia, left bundle branch block, cardiac pacemaker or significant atrial tachyarrythmias, as defined by the need for treatment
  10. Previous treatment with docetaxel or an Axl inhibitor
  11. Current treatment with agents that may prolong QT interval and may cause Torsade de Points which cannot be discontinued at least five half-lives prior to treatment. Please see Appendix J for list of relevant medications
  12. Known family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy
  13. Previous history of Grade 3 or worse drug-induced QTc prolongation requiring treatment withdrawal
  14. Screening 12-lead ECG with a measurable QTc interval according to Fridericia's correction >450 ms
  15. Ongoing infection requiring systemic treatment
  16. Inability to tolerate oral medication
  17. Impaired coagulation as evidenced by:
    • INR >1.5 times ULN, or
    • aPTT > 1.5 times ULN
  18. Clinically active existing gastrointestinal disease affecting drug absorption, such as celiac disease or Crohn's disease
  19. Previous bowel resection anticipated to affect drug absorption
  20. Any evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
  21. Treatment with any medication which is predominantly metabolized by CYP3A4 and has a narrow therapeutic index
  22. Active, uncontrolled central nervous system (CNS) disease
  23. Known active infection with human immunodeficiency virus (HIV), hepatitis B or C viruses (screening not required)
  24. Major surgery within 28 days prior to the start of BGB324, excluding skin biopsies and procedures for insertion of central venous access devices
Open or close this module Contacts/Locations
Central Contact Person: Joyce Bolluyt, RN
Telephone: 214-648-7097
Study Officials: David E Gerber, MD
Principal Investigator
University of Texas Southwestern Medical Center
Locations: United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75063
Contact:Contact: Joyce Bolluyt, RN 214-648-7097
Covenant Health Systems/Joe Arrington Cancer Treatment and Research Center
Lubbock, Texas, United States, 79410
Contact:Contact: Donald P Quick, MD 806-725-8000
Contact:Sub-Investigator: Donald P Quick, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
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