Non-small Cell Lung CancerPhase 2TH-4000NCT02454842
Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) Patients
A Phase 2 study testing TH-4000 (Tarloxotinib) in people with Non-small Cell Lung Cancer and NSCLC, run by Rain Oncology Inc at 12 sites in 2 countries.
Trial summary
This phase 2 study is designed to evaluate the safety and activity of TH-4000 a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, NSCLC, Non-squamous NSCLC
- What is being tested?
- TH-4000 (Tarloxotinib)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 2015to 31 Jan 2017
- Phase
- Phase 2
- 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
None listed.
Who cannot join
- Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication
- Family history of long corrected QT interval (QTc) syndrome
- Symptomatic central nervous system (CNS) lesions
- Radiation therapy within 2 weeks prior to the first dose of study medication
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
- Concurrent active malignancy requiring systemic treatment
- Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures
- Pregnant or breast-feeding
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, 27514
UT Southwestern Medical Center
Dallas, Texas, 75235
University of Southern California-Norris
Los Angeles, California, 90033
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, 37232
University of Pennsylvania-Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403
Swedish Cancer Institute
Seattle, Washington, 98104
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 2 Study of TH-4000 (Tarloxotinib) in Patients With EGFR-Mutant, T790M-Negative, Advanced Non-Small Cell Lung Cancer Progressing on an EGFR Tyrosine Kinase Inhibitor
This phase 2 study is designed to evaluate the safety and activity of TH-4000 a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC.
Read the detailed description
A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy.
Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.
- Conditions
- Non-small Cell Lung Cancer, NSCLC, Non-squamous NSCLC
- Being tested
- TH-4000 (Tarloxotinib)
- Keywords
- TH-4000, low-oxygen conditions, hypoxia, non-small cell lung cancer, NSCLC, squamous cell carcinoma, Tarloxotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Hypoxia, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH-4000 (Tarloxotinib)Drug
TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug
| Study group | Role | What they receive |
|---|---|---|
| TH-4000 (Tarloxotinib) | Experimental | TH-4000 (Tarloxotinib), 150 mg/m2 will be administered by IV infusion on Days 1, 8, 15, and 22 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity Receives: Drug: TH-4000 (Tarloxotinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with response rate as evaluated by RECIST criteria
Measured: Approximately 12 months
Secondary outcomes (10)
Incidence of adverse events (AEs)
Measured: Up to 30 days after last dose
Type of adverse events (AEs)
Measured: Up to 30 days after last dose
Severity of adverse events (AEs)
Measured: Up to 30 days after last dose
Duration of response (DOR) calculated for all patients achieving an objective response
Measured: Approximately 12 months
Progression-free survival (PFS)
Measured: Approximately 12 months
Overall Survival (OS)
Measured: Approximately 12 months
Time to peak plasma concentration (Tmax)
Time to peak plasma concentration (Tmax), maximum plasma concentration (Cmax), area under concentration-time curve (AUC)
Measured: Cycle 1 Day 1 predose and up to 24 hours post dose
Maximum plasma concentration (Cmax)
Measured: Cycle 1 Day 1 predose and up to 24 hours post dose
Area under concentration-time curve (AUC)
Measured: Cycle 1 Day 1 predose and up to 24 hours post dose
QTc Interval
Measured: Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 of subsequent cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completion31 Jan 2017
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rain Oncology Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Liu, Principal investigator, Georgetown University Hospital Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454842
- Sponsor's protocol ID
- TH-CR-601
- Acronym
- TH-4000
- Status last verified
- Jan 2023
- First submitted
- 4 May 2015
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of TH-4000 (Tarloxotinib) in Patients With EGFR-Mutant, T790M-Negative, Advanced Non-Small Cell Lung Cancer Progressing on an EGFR Tyrosine Kinase Inhibitor
- ClinicalTrials.gov ID
- NCT02454842
- Acronym / sponsor ID
- TH-4000 / TH-CR-601
- Conditions
- Non-small Cell Lung Cancer, NSCLC, Non-squamous NSCLC
- Keywords
- TH-4000, low-oxygen conditions, hypoxia, non-small cell lung cancer, NSCLC, squamous cell carcinoma, Tarloxotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rain Oncology IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 study is designed to evaluate the safety and activity of TH-4000 a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC.
Detailed description
A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy.
Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TH-4000 (Tarloxotinib) | Experimental | Drug: TH-4000 (Tarloxotinib)TH-4000 (Tarloxotinib), 150 mg/m2 will be administered by IV infusion on Days 1, 8, 15, and 22 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication
- Family history of long corrected QT interval (QTc) syndrome
- Symptomatic central nervous system (CNS) lesions
- Radiation therapy within 2 weeks prior to the first dose of study medication
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TH-4000 (Tarloxotinib)TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug | Drug | TH-4000 (Tarloxotinib) |
Primary outcome
Number of participants with response rate as evaluated by RECIST criteria
Time frame: Approximately 12 months
10 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 30 days after last dose
Type of adverse events (AEs)
Time frame: Up to 30 days after last dose
Severity of adverse events (AEs)
Time frame: Up to 30 days after last dose
Duration of response (DOR) calculated for all patients achieving an objective response
Time frame: Approximately 12 months
Progression-free survival (PFS)
Time frame: Approximately 12 months
Overall Survival (OS)
Time frame: Approximately 12 months
Time to peak plasma concentration (Tmax)
Time frame: Cycle 1 Day 1 predose and up to 24 hours post dose
Maximum plasma concentration (Cmax)
Time frame: Cycle 1 Day 1 predose and up to 24 hours post dose
Area under concentration-time curve (AUC)
Time frame: Cycle 1 Day 1 predose and up to 24 hours post dose
QTc Interval
Time frame: Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 of subsequent cycles
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Liu principal investigator
Georgetown University Hospital Cancer Center
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TH-4000 (Tarloxotinib) in people with Non-small Cell Lung Cancer and NSCLC, run by Rain Oncology Inc at 12 sites in 2 countries.
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 0 inclusion and 8 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: stopped early, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
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?
Number of participants with response rate as evaluated by RECIST criteria (time frame: Approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023.