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

Primary Purpose

Locally Advanced or Metastatic Solid Carcinomas, Colon Cancer, Cholangiocarcinoma

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

TRK-950

About this trial

This is an interventional treatment trial for Locally Advanced or Metastatic Solid Carcinomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic
HonorHealth Research Institute
Centre Léon Bérard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm 1 - TRK-950

Arm 2 - TRK-950

Arm 3 -TRK-950

Arm Description

Solid tumor TRK-950 (Three dose levels will be explored during Arm 1)

Colon cancer TRK-950 (Low dose and High dose)

Cholangiocarcinomas TRK-950 (Low dose)

Outcomes

Primary Outcome Measures

Adverse event

CTCAE version 4.03

Blood pressure (mmHg)

Heart rate (bpm)

Respiratory rate (bpm)

Temperature (°F or °C)

Weight (lbs/kg)

Height (inches/cm)

Karnofsky performance status

Electrocardiogram

Clinical laboratory tests

Secondary Outcome Measures

Area under the concentration curve(AUC)

Maximum plasma concentration(Cmax)

Time to maximum plasma concentration(Tmax)

Terminal elimination half life(t1/2)

Total body clearance(CL)

Apparent volume of distribution(Vd)

Tumor response rate

Duration of response

Time to progression

Progression free survival

Full Information

NCT ID

NCT02990481

First Posted

November 29, 2016

Last Updated

October 14, 2021

Sponsor

Toray Industries, Inc

1. Study Identification

Unique Protocol Identification Number

NCT02990481

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 6, 2017 (Actual)

Primary Completion Date

September 16, 2019 (Actual)

Study Completion Date

September 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Toray Industries, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent To establish the dose of TRK-950 recommended for future phase 2 studies

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced or Metastatic Solid Carcinomas, Colon Cancer, Cholangiocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 - TRK-950

Arm Type

Experimental

Arm Description

Solid tumor TRK-950 (Three dose levels will be explored during Arm 1)

Arm Title

Arm 2 - TRK-950

Arm Type

Experimental

Arm Description

Colon cancer TRK-950 (Low dose and High dose)

Arm Title

Arm 3 -TRK-950

Arm Type

Experimental

Arm Description

Cholangiocarcinomas TRK-950 (Low dose)

Intervention Type

Biological

Intervention Name(s)

TRK-950

Intervention Description

Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle

Intervention Type

Biological

Intervention Name(s)

TRK-950

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

TRK-950

Intervention Description

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

Primary Outcome Measure Information:

Title

Adverse event

Time Frame