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Solid TumorsPhase 1/2NCT02048488

A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas

A Phase 1/2 study testing TSR-011 in people with Solid Tumors and Lymphomas, run by Tesaro, Inc. at 15 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including: 1. Anaplastic lymphoma kinase (ALK) 2. The tropomyosin-related kinases TRKA, TRKB, and TRKC This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, Lymphomas
What is being tested?
TSR-011
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
15 sitesin 5 countries
Study dates
Oct 2012to Jun 2018
Phase
Phase 1/2
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

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Patient has a known history of or active (treated or not) Hepatitis B or C.
  • Patient has presence of ascites causing significant symptoms.
  • A patient must stop taking any prescription, over-the-counter, or herbal remedy known to be an inhibitor or inducer of CYP3A4/5.

Trial locations and contacts

15 sites in 5 countries.

15 sites in 5 countries

United States6 sites

  • Study site

    Goodyear, Arizona

  • Study site

    Los Angeles, California

  • Study site

    Nashville, Tennessee

  • Study site

    Norfolk, Virginia

  • Study site

    Scottsdale, Arizona

  • Study site

    Spokane, Washington

Other trials in United States

Poland4 sites

  • Study site

    Gdansk, Pomeranian Voivodeship

  • Study site

    Olsztyn, Warmian-Masurian Voivodeship

  • Study site

    Poznan, Greater Poland Voivodeship

  • Study site

    Warsaw, Masovian Voivodeship

Other trials in Poland

Spain2 sites

  • Study site

    Madrid

  • Study site

    Santiago de Compostela

Other trials in Spain

Taiwan2 sites

  • Study site

    Tainan

  • Study site

    Taipei

Other trials in Taiwan

United Kingdom1 site

  • Study site

    London

Other trials in United Kingdom

About this study

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

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

This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended phase 2 dose.

Being tested
TSR-011
Keywords
non small cell lung cancer, NSCLC, Anaplastic lymphoma kinase, ALK tyrosine kinase receptor, ALK+, TRK+, ALK inhibitor, TRK inhibitor, tropomyosin receptor kinase, TRKA, TRKB, TRKC, advanced malignancy
Medical subject headings
Lymphoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TSR-011Drug

    Also called ALK inhibitor, ALKi, TRK inhibitor

    Number of cycles until progression or unacceptable toxicity develops.

Study groups in NCT02048488
Study groupRoleWhat they receive
Experimental Drug TSR-011ExperimentalExperimental Drug TSR-011
Receives: Drug: TSR-011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs)

    Measured: Approximately 2 years

Secondary outcomes (6)

  1. Area Under the Concentration-Time Curve (AUC)

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

  2. Maximum Tolerated Dose (MTD)

    Phase 1, during the dose-escalation phase

    Measured: 28 days after first dose

  3. Response Rate (RR)

    Phase 2

    Measured: approximately 2 years

  4. Dose limiting toxicity (DLT)

    Phase 1, during the dose escalation phase

    Measured: 28 days after first dose

  5. Progression Free Survival (PFS)

    Phase 2

    Measured: approximately 2 years

  6. Recommended Phase 2 Dose (RP2D)

    Phase 1

    Measured: approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2014 (estimated)
  2. Study startOct 2012
  3. Primary completionSep 2016
  4. Study completionJun 2018

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02048488
Sponsor's protocol ID
PR-20-5006-C
Status last verified
Mar 2016
First submitted
20 Jan 2014
Last updated
26 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31217479

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TSR-011 in people with Solid Tumors and Lymphomas, run by Tesaro, Inc. at 15 sites in 5 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 13 inclusion and 18 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: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Poland, Spain, Taiwan, United Kingdom. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Adverse Events (AEs) (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02048488, which also lists 1 linked publication.

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 26 Mar 2019.

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