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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04849273




Registration number
NCT04849273
Ethics application status
Date submitted
12/04/2021
Date registered
19/04/2021
Date last updated
26/05/2023

Titles & IDs
Public title
A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
Scientific title
A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
Secondary ID [1] 0 0
CA226-1036
Secondary ID [2] 0 0
CA226-1036
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Non-Small Cell Lung Cancer 0 0
NSCLC 0 0
Advanced Solid Tumor 0 0
Metastatic Solid Tumor 0 0
ALK Gene Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TPX-0131

Experimental: TPX-0131 - The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131.


Treatment: Drugs: TPX-0131
Oral TPX-0131 tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131
Timepoint [1] 0 0
Within 28 days of the first TPX-0131 dose for each patient
Primary outcome [2] 0 0
Define the Recommended Phase 2 Dose
Timepoint [2] 0 0
Approximately 24 months
Secondary outcome [1] 0 0
Adverse events (AEs)
Timepoint [1] 0 0
Approximately 34 months

Eligibility
Key inclusion criteria
* Age = 18 (or as required by local regulation).
* Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC.
* Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase 1.
* ECOG performance status = 1.
* Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
* Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
* Adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Major surgery within four weeks of the start of TPX-0131 treatment.
* Clinically significant cardiovascular disease
* Any of the following cardiac criteria:

* Mean resting corrected QT interval (QTc) > 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
* Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
* Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
* Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
* Subjects with current or anticipated need for drugs that are sensitive CYP2C9 substrates with narrow therapeutic indices.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/04/2023
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 6102 - Blacktown
Recruitment hospital [2] 0 0
Local Institution - 6103 - Heidelberg
Recruitment hospital [3] 0 0
Local Institution - 6104 - Melbourne
Recruitment hospital [4] 0 0
Local Institution - 6101 - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul-teukbyeolsi
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Turning Point Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC).
Trial website
https://clinicaltrials.gov/study/NCT04849273
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04849273