Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990481
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 twelve (12) patients will be enrolled in Arm 3.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 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
Actual Primary Completion Date : September 16, 2019
Actual Study Completion Date : September 16, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • 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, immunotherapy, 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
France
Centre Léon Bérard
Lyon, France, 69373
Sponsors and Collaborators
Toray Industries, Inc
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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