NCT02048488

Brief Summary

TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including:

  1. 1.Anaplastic lymphoma kinase (ALK)
  2. 2.The tropomyosin-related kinases TRKA, TRKB, and TRKC

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_1

Geographic Reach
5 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2016

Enrollment Period

3.9 years

First QC Date

January 20, 2014

Last Update Submit

March 25, 2019

Conditions

Solid TumorsLymphomas

Keywords

non small cell lung cancerNSCLCAnaplastic lymphoma kinaseALK tyrosine kinase receptorALK+TRK+ALK inhibitorTRK inhibitortropomyosin receptor kinaseTRKATRKBTRKCadvanced malignancy

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events (AEs)

    Approximately 2 years

Secondary Outcomes (6)

  • Area Under the Concentration-Time Curve (AUC)

    Day 1: 0-24 hrs after first dose; pre-dose on days 8 & 15; day 29: 0-24 hours

  • Maximum Tolerated Dose (MTD)

    28 days after first dose

  • Response Rate (RR)

    approximately 2 years

  • Dose limiting toxicity (DLT)

    28 days after first dose

  • Progression Free Survival (PFS)

    approximately 2 years

  • +1 more secondary outcomes

Study Arms (1)

Experimental Drug TSR-011

EXPERIMENTAL

Experimental Drug TSR-011

Drug: TSR-011

Interventions

TSR-011DRUG

Number of cycles until progression or unacceptable toxicity develops.

Also known as: ALK inhibitor, ALKi, TRK inhibitor
Experimental Drug TSR-011

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be considered eligible to participate in this study, all of the following requirements must be met:
  • Patients in Phase 1 must have metastatic or locally advanced solid tumors who have failed to respond to standard therapy
  • All patients must have confirmation of either ALK positive or TRK positive status.
  • Patients in Phase 1 will not be required to have measurable disease. All patients in Phase 2a will be required to have measurable disease by RECIST.
  • All patients enrolled in this study must have tumor tissue available.
  • Patient (male or female) must be ≥ 18 years of age (except where age of majority is 16 years in a particular country, such as the United Kingdom).
  • Patient must have performance status ≤2 on the ECOG Performance Scale.
  • Patient must have an estimated life expectancy of at least 3 months.
  • Patients must have adequate organ function.
  • For patients previously treated with myelosuppressive therapy, at least 3 weeks must have elapsed and toxicity must have recovered to grade 1 or baseline. Non-myelosuppressive therapy patients must have recovered from all treatment-related toxicities. Fourteen days must have elapsed since palliative radiation for bone metastasis.
  • Female patients of childbearing potential must have a negative serum pregnancy test and use adequate birth control for the duration of study participation and for 3 months after the last dose of study drug.
  • The patient or his or her legal representative must be able to read, understand, and provide signed informed consent.
  • Patient is able to understand the study procedures and agrees to participate in the study by giving written informed consent.

You may not qualify if:

  • Patients will not be deemed eligible for entry into this study if any of the following criteria are met:
  • Patient has leukemia.
  • Patient is a pregnant or lactating female.
  • Patient has uncontrolled congestive heart failure, angina, or has had a myocardial infarction in the preceding 3 months.
  • Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade, or QTc interval \>450 msec.
  • Patients with risk factors for Torsade de point and patients receiving concomitant medication with QT-prolonging medicines.
  • Patient has an uncontrolled concurrent medical condition or disease.
  • Patient has undergone bone marrow or stem cell transplantation in the past 6 months.
  • Patient has a known hypersensitivity to the components of TSR-011 or the excipients.
  • Patient has active or uncontrolled infection.
  • Patient has a known psychiatric or substance abuse disorder.
  • Patient has active second primary malignancy.
  • Patient is observed to have a clinically active central nervous system (CNS) metastases or carcinomatous meningitis.
  • Patient has any other severe concurrent disease which, in the judgment of the Investigator, would preclude study participation.
  • Patient is known to be HIV positive or who has an AIDS-related illness.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Goodyear, Arizona, United States

Location

Unknown Facility

Scottsdale, Arizona, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

Unknown Facility

Poznan, Greater Poland Voivodeship, Poland

Location

Unknown Facility

Warsaw, Masovian Voivodeship, Poland

Location

Unknown Facility

Gdansk, Pomeranian Voivodeship, Poland

Location

Unknown Facility

Olsztyn, Warmian-Masurian Voivodeship, Poland

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Santiago de Compostela, Spain

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

  • Lin CC, Arkenau HT, Lu S, Sachdev J, de Castro Carpeno J, Mita M, Dziadziuszko R, Su WC, Bobilev D, Hughes L, Chan J, Zhang ZY, Weiss GJ. A phase 1, open-label, dose-escalation trial of oral TSR-011 in patients with advanced solid tumours and lymphomas. Br J Cancer. 2019 Jul;121(2):131-138. doi: 10.1038/s41416-019-0503-9. Epub 2019 Jun 20.

    PMID: 31217479DERIVED

MeSH Terms

Conditions

LymphomaCarcinoma, Non-Small-Cell Lung

Interventions

belizatinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dmitri Bobilev, MD

    Tesaro, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 29, 2014

Study Start

October 1, 2012

Primary Completion

September 1, 2016

Study Completion

June 1, 2018

Last Updated

March 26, 2019

Record last verified: 2016-03

Locations

US(6)ES(2)TW(2)GB(1)PL(4)