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Small Molecule Inhibitor

BGB324 + Docetaxel for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By David E Gerber, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiographic disease recurrence or progression during or after the last line of chemotherapy
Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days or 2 cycles of 21 days
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it's safe when combined with another existing cancer drug. They're also trying to find the highest dose that doesn't cause too many side effects.

Who is the study for?
Adults over 18 with advanced stage non-small cell lung cancer (NSCLC) who've had up to three prior treatments, including platinum-based therapy. They must have adequate liver and kidney function, controlled brain metastases if present, and no severe heart issues or uncontrolled diseases. Participants need measurable disease progression after the last treatment and resolved previous treatment toxicities. Women of childbearing potential must test negative for pregnancy.Check my eligibility
What is being tested?
The trial is testing BGB324 in combination with docetaxel to find the highest dose patients can tolerate without severe side effects. BGB324 is an investigational drug, and participants will receive it alongside docetaxel, a chemotherapy medication already used in treating NSCLC.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as fatigue, nausea, hair loss (alopecia), low blood counts leading to increased infection risk or bleeding tendencies. Specific side effects of BGB324 are not detailed but may include reactions related to immune system activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has grown or returned after my last chemotherapy.
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My kidney function is good, with creatinine levels low or clearance high.
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I've had up to 3 cancer treatments, including one platinum-based.
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My lung cancer is confirmed to be at stage 4.
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I am not pregnant, can use birth control during the study, and if female, am not of childbearing potential or will use contraception.
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It has been weeks since my last cancer treatment or major surgery.
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My liver tests are within normal ranges, or slightly elevated if I have liver cancer.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer has worsened after targeted therapy and chemotherapy.
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My blood counts meet the required levels for treatment.
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I had treatment for brain cancer spread and don't need steroids.
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My side effects from previous treatments are mild or gone, except for hair loss.
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I have enough tissue samples for testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days or 2 cycles of 21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days or 2 cycles of 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the maximum tolerated dose of BGB324 in combination with docetaxel

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: BGB324 in combination with docetaxelExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BGB324
2016
Completed Phase 1
~30
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,048,076 Total Patients Enrolled
Texas Tech University Health Sciences CenterOTHER
103 Previous Clinical Trials
10,621 Total Patients Enrolled
BerGenBio ASAIndustry Sponsor
13 Previous Clinical Trials
874 Total Patients Enrolled

Media Library

BGB324 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02922777 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: BGB324 in combination with docetaxel
Non-Small Cell Lung Cancer Clinical Trial 2023: BGB324 Highlights & Side Effects. Trial Name: NCT02922777 — Phase 1
BGB324 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02922777 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation for this research project?

"This trial is no longer recruiting new patients, as the last update took place on June 28th 2022. If you're interested in other research studies related to non-small cell lung carcinoma (nsclc), there are currently 1,527 trials open for enrollment and 323 clinical trials focused on BGB324 that need participants."

Answered by AI

Has the regulatory body approved of BGB324 for public consumption?

"The safety of BGB324 is estimated to be a 1 on the scale due its status as an early-phase trial with limited evidence for both efficacy and security."

Answered by AI

Is enrollment currently possible for this investigation?

"According to clinicaltrials.gov, this trial has ceased participant recruitment and is no longer enrolling patients. Initially posted on November 1st 2016, the study was last updated on June 28th 2022; however, there are over 1800 other medical trials actively recruiting at present."

Answered by AI

Has BGB324 been tested in any other scientific research projects?

"Presently, there are 323 trials in progress for BGB324 with 126 of those experiments being located at Phase 3. While the majority take place around Fuzhou, Fujian, a total of 22403 sites are running studies for this drug regimen."

Answered by AI

What therapeutic benefits has BGB324 been known to provide?

"BGB324 is the go-to medication for treating malignant neoplasms and has been observed to provide benefit in other conditions, such as advance directives, sarcoma, and esophageal neoplasms."

Answered by AI
~3 spots leftby Mar 2025