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A Study of TRK-950 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990481
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc

Study Description
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Brief Summary:
  1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
  2. To establish the dose of TRK-950 recommended for future phase 2 studies

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Solid Carcinomas Colon Cancer Cholangiocarcinoma Biological: TRK-950 Phase 1

Detailed Description:

This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1.

Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively.

In parallel, to determine anti-tumor activity up to six (12) patients will be enrolled in Arm 3.

Once the dosing schedule has been established in Arm 2, up to 40 additional patients may be enrolled in Arm 4 for confirmation of safety.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 - TRK-950
  • Solid tumor
  • TRK-950 (Three dose levels will be explored during Arm 1)
 Biological: TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
Experimental: Arm 2 - TRK-950
  • Colon cancer
  • TRK-950 (Low dose and High dose)
 Biological: TRK-950

Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle

High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle
Experimental: Arm 3 -TRK-950
  • Cholangiocarcinomas
  • TRK-950 (Low dose)
 Biological: TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
Experimental: Arm 4 - TRK-950
  • Colon, gastric, ovarian, bladder cancers, as well as cholangiocarcinomas or hepatomas
  • TRK-950 (Low or High dose: dose level will be determined by the schedule of either low dose or high dose of Arm 2)
 Biological: TRK-950
Complying with the schedule of either low or high dose of Arm 2 as appropriate for the chosen schedule.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse event [ Time Frame: through study completion, an average of 1 year ]
  2. CTCAE version 4.03 [ Time Frame: through study completion, an average of 1 year ]
  3. Blood pressure (mmHg) [ Time Frame: through study completion, an average of 1 year ]
  4. Heart rate (bpm) [ Time Frame: through study completion, an average of 1 year ]
  5. Respiratory rate (bpm) [ Time Frame: through study completion, an average of 1 year ]
  6. Temperature (°F or °C) [ Time Frame: through study completion, an average of 1 year ]
  7. Weight (lbs/kg) [ Time Frame: through study completion, an average of 1 year ]
  8. Height (inches/cm) [ Time Frame: through study completion, an average of 1 year ]
  9. Karnofsky performance status [ Time Frame: through study completion, an average of 1 year ]
  10. Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
  11. Clinical laboratory tests [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Area under the concentration curve(AUC) [ Time Frame: through study completion, an average of 1 year ]
  2. Maximum plasma concentration(Cmax) [ Time Frame: through study completion, an average of 1 year ]
  3. Time to maximum plasma concentration(Tmax) [ Time Frame: through study completion, an average of 1 year ]
  4. Terminal elimination half life(t1/2) [ Time Frame: through study completion, an average of 1 year ]
  5. Total body clearance(CL) [ Time Frame: through study completion, an average of 1 year ]
  6. Apparent volume of distribution(Vd) [ Time Frame: through study completion, an average of 1 year ]
  7. Tumor response rate [ Time Frame: through study completion, an average of 1 year ]
  8. Duration of response [ Time Frame: through study completion, an average of 1 year ]
  9. Time to progression [ Time Frame: through study completion, an average of 1 year ]
  10. Progression free survival [ Time Frame: through study completion, an average of 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1
  • Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2
  • Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3
  • Patients with histologically confirmed locally advanced or metastatic colon, gastric, ovarian, bladder cancers, as well as cholangiocarcinomas or hepatomas in Arm 4
  • Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
  • Measurable disease per RECIST 1.1 (primary or metastases)

Exclusion Criteria:

  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Pregnant or nursing women
  • Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within four weeks prior to study entry
  • Unwillingness or inability to comply with procedures required in this protocol
  • Known active infection with HIV, hepatitis B, hepatitis C
  • Symptomatic brain metastases
  • Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • Patients who are currently receiving any other investigational agent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990481


Contacts
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Contact: Angela Iheanacho, MS 602 358 8326 aiheanacho@TD2inc.com
Contact: Saif Majeed, BPharm, PhD 602 358 8351 SMajeed@td2inc.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Clinical Trials Office    855-776-0015      
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN,RN,AOCNS    480-323-1339      
France
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Philippe Cassier, M.D.    +33 (0)4 26 55 68 33      
Sponsors and Collaborators
Toray Industries, Inc
More Information
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Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT02990481    
Other Study ID Numbers: 950P1V01
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms
Adenocarcinoma
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type