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Non-Small Cell Lung CarcinomaPhase 1NCT02922777

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

A Phase 1 study testing BGB324 and Docetaxel in people with Non-Small Cell Lung Carcinoma, run by University of Texas Southwestern Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Carcinoma
What is being tested?
BGB324 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
2 sitesUnited States
Study dates
Nov 2016to 4 Apr 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Previous treatment-associated toxicities resolved to CTCAE grade ≤2 (except alopecia)
  • Adequate archival tissue (10-15 slides, or 5 slides with 3 sections per slide) for biomarker analysis
  • 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

Who cannot join

  • 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
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  • 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
  • Ongoing infection requiring systemic treatment
  • Inability to tolerate oral medication
  • Impaired coagulation as evidenced by:
  • INR >1.5 times ULN, or
  • aPTT > 1.5 times ULN
  • Clinically active existing gastrointestinal disease affecting drug absorption, such as celiac disease or Crohn's disease
  • Previous bowel resection anticipated to affect drug absorption
  • 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
  • Treatment with any medication which is predominantly metabolized by CYP3A4 and has a narrow therapeutic index
  • Active, uncontrolled central nervous system (CNS) disease
  • Known active infection with human immunodeficiency virus (HIV), hepatitis B or C viruses (screening not required)
  • Major surgery within 28 days prior to the start of BGB324, excluding skin biopsies and procedures for insertion of central venous access devices

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75063

  • Covenant Health Systems/Joe Arrington Cancer Treatment and Research Center

    Lubbock, Texas, 79410

Other trials in United States

About this study

Official title: Phase 1 Trial of Dose Escalated BGB324 in Combination With Docetaxel for Previously Treated Advanced Non-small Cell Lung Cancer (NSCLC)

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.

Read the 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).

Being tested
BGB324, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB324Drug

    75 mg/m2 every 21 days

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 given IV every 21 days

Study groups in NCT02922777
Study groupRoleWhat they receive
BGB324 in combination with docetaxelExperimentalThe 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.
Receives: Drug: BGB324; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 42 days or 2 cycles of 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion6 Feb 2023
  4. Study completion4 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02922777
Sponsor's protocol ID
STU 052015-077
Status last verified
Feb 2024
First submitted
19 May 2016
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BGB324 and Docetaxel in people with Non-Small Cell Lung Carcinoma, run by University of Texas Southwestern Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the maximum tolerated dose of BGB324 in combination with docetaxel (time frame: 42 days or 2 cycles of 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02922777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.

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