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A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC

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ClinicalTrials.gov Identifier: NCT04849273
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Turning Point Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 12, 2021
First Posted Date  ICMJE April 19, 2021
Last Update Posted Date November 22, 2021
Actual Study Start Date  ICMJE August 2, 2021
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
  • Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131 [ Time Frame: Within 28 days of the first TPX-0131 dose for each patient ]
    Evaluate the safety and tolerability of TPX-0131
  • Define the Recommended Phase 2 Dose [ Time Frame: Approximately 22 months ]
    Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131
  • Define the objective response rate (ORR) [ Time Frame: Approximately 44 months ]
    Determine the preliminary efficacy by the ORR in defined cohorts with ALK+ advanced or metastatic NSCLC
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2021)
  • Duration of Response (DOR) [ Time Frame: Approximately 44 months ]
    Determine the DOR of TPX-0131
  • Time to response (TTR) [ Time Frame: Approximately 44 months ]
    Determine the TTR of TPX-0131
  • Clinical benefit rate (CBR) [ Time Frame: Approximately 44 months ]
    Determine the CBR of TPX-0131
  • Intracranial tumor response [ Time Frame: Approximately 44 months ]
    Determine the intracranial tumor response in subjects with measurable brain metastases, as determined by BICR.
  • Progression free survival (PFS) [ Time Frame: Approximately 44 months ]
    Determine the PFS of TPX-0131
  • Overall survival (OS) [ Time Frame: Approximately 44 months ]
    Determine the efficacy and safety of TPX-0131
  • Adverse events (AEs) [ Time Frame: Approximately 44 months ]
    Evaluate the overall safety profile of TPX-0131
  • CNS Progression-Free Survival (CNS-PFS) [ Time Frame: Approximately 44 months ]
    Determine the CNS-PFS in patients with measurable brain metastases using Modified RECIST v1.1
  • Cmax (maximum plasma concentration) of TPX-0131 [ Time Frame: Up to 120 hours post-dose ]
    Evaluate the maximum plasma concentration of TPX-0131
  • AUC (area under plasma concentration time curve) of TPX-0131 [ Time Frame: Up to 120 hours post-dose ]
    Determine the AUC of TPX-0131
  • Patient-reported quality of life - Core Quality of Life Questionnaire [ Time Frame: Approximately 44 months ]
    Estimate the effect of TPX-0131 on patient-reported outcomes using the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire to assess subject's ability to complete 30 daily activities. The scale, from 1 to 4 (1 = not difficult to 4 = very difficult), indicates the level of difficulty to complete a task.
  • Patient-reported quality of life - Lung Cancer Quality of Life Questionnaire [ Time Frame: Approximately 44 months ]
    Estimate the effect of TPX-0131 on patient-reported outcomes, using the Lung Cancer Quality of Life Questionnaire asks questions related to 13 specific lung cancer symptoms. The scale, from 1 to 4 (1 = not often to 4 = very often), indicates the frequency of symptoms experienced in a given week.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
Official Title  ICMJE A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
Brief Summary A phase 1/2, 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). The study consists of two portions: 1) Phase 1 dose escalation, and 2) Phase 2 efficacy evaluation.
Detailed Description

Phase 1 Dose Escalation: To evaluate the overall safety profile, efficacy of TPX-0131 in pretreated subjects with ALK+ advanced or metastatic NSCLC.

Phase 2 Efficacy Evaluation: To determine the safety and anti-tumor efficacy of TPX-0131 in defined cohorts of subjects with advanced or metastatic ALK+ NSCLC.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • ALK Gene Mutation
Intervention  ICMJE Drug: TPX-0131
Oral TPX-0131 tablets
Study Arms  ICMJE Experimental: TPX-0131

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

The Phase 2 part of the study will determine the safety, tolerability, PK and preliminary efficacy of TPX-0131 in specific cohorts.

Intervention: Drug: TPX-0131
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2021)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2026
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric Park, M.D (858) 276-0005 clinical@tptherapeutics.com
Listed Location Countries  ICMJE Australia,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04849273
Other Study ID Numbers  ICMJE TPX-0131-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Turning Point Therapeutics, Inc.
Study Sponsor  ICMJE Turning Point Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Park, M.D. Turning Point Therapeutics
PRS Account Turning Point Therapeutics, Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP