Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.

NCT02922777 | Completed Phase 1 DMC

• 1 other identifier: STU 052015-077
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose of BGB324 in combination with docetaxel

  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.

  42 days or 2 cycles of 21 days

Study Arms (1)

BGB324 in combination with docetaxel

EXPERIMENTAL

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; Drug: Docetaxel

Interventions

BGB324 DRUG

75 mg/m2 every 21 days

BGB324 in combination with docetaxel

Docetaxel DRUG

75 mg/m2 given IV every 21 days

Also known as: Taxotere

BGB324 in combination with docetaxel

Eligibility Criteria

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

You may qualify if:

• A patient is eligible for the study if the following criteria are met:
• Provision of written informed consent to participate in this investigational study
• Histologically or cytologically confirmed advanced (stage 4, according to the American Joint Committee on Cancer \[AJCC\] Staging manual) NSCLC
• 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.
• Radiographic disease recurrence or progression during or after the last line of chemotherapy
• 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
• European Cooperative Oncology Group (ECOG) performance status 0 or 1
• Age 18 years or older
• Measurable or evaluable disease according to RECIST v1.1
• Previously treated brain metastases (surgery and/or radiation therapy) are eligible, provided that patients are asymptomatic and not requiring corticosteroids
• 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
• Adequate hematologic function (absolute neutrophil count \[ANC\] ≥ 1500 cells/µL; hemoglobin ≥ 9 g/dL; platelets ≥ 100,000/µL
• Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation)
• 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

You may not qualify if:

• A patient is excluded from the study if any of the following criteria are met:
• Pregnant or lactating
• 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%)
• History of an ischemic cardiac event including myocardial infarction within 3 months of study entry
• NSCLC with evidence of a centrally cavitating lesion
• Peripheral neuropathy NCI CTCAE ≥Grade 2 at baseline
• Pulmonary hemorrhage or hemoptysis \> 2.5 mL blood within 6 weeks (or within 2 weeks if source definitively treated \[eg, radiation therapy or bronchoscopic procedure\])
• 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
• 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 tachyarrhythmias , as defined by the need for treatment
• Previous treatment with docetaxel or an Axl inhibitor
• 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
• Known family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy
• Previous history of Grade 3 or worse drug-induced QTc prolongation requiring treatment withdrawal
• Screening 12-lead ECG with a measurable QTc interval according to Fridericia's correction \>450 ms

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Texas Tech University Health Sciences Center: collaborator
• BerGenBio ASA: collaborator

Study Sites (2)

University of Texas Southwestern Medical Center

Dallas, Texas, 75063, United States

Location

Covenant Health Systems/Joe Arrington Cancer Treatment and Research Center

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

bemcentinib; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• David E Gerber, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Internal Medicine

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: October 4, 2016
• Study Start: November 1, 2016
• Primary Completion: February 6, 2023
• Study Completion: April 4, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)