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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990481
• Other study ID #: 950P1V01
• Status: Completed
• Phase: Phase 1
• Start date: March 6, 2017
• Est. completion date: September 16, 2019

Study information

• Verified date: November 2020
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Colon Cancer
• Locally Advanced or Metastatic Solid Carcinomas

Intervention

Biological:
• TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
• 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
• TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon
United States	Mayo Clinic	Phoenix	Arizona
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries, Inc

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event		through study completion, an average of 1 year
Primary	CTCAE version 4.03		through study completion, an average of 1 year
Primary	Blood pressure (mmHg)		through study completion, an average of 1 year
Primary	Heart rate (bpm)		through study completion, an average of 1 year
Primary	Respiratory rate (bpm)		through study completion, an average of 1 year
Primary	Temperature (°F or °C)		through study completion, an average of 1 year
Primary	Weight (lbs/kg)		through study completion, an average of 1 year
Primary	Height (inches/cm)		through study completion, an average of 1 year
Primary	Karnofsky performance status		through study completion, an average of 1 year
Primary	Electrocardiogram		through study completion, an average of 1 year
Primary	Clinical laboratory tests		through study completion, an average of 1 year
Secondary	Area under the concentration curve(AUC)		through study completion, an average of 1 year
Secondary	Maximum plasma concentration(Cmax)		through study completion, an average of 1 year
Secondary	Time to maximum plasma concentration(Tmax)		through study completion, an average of 1 year
Secondary	Terminal elimination half life(t1/2)		through study completion, an average of 1 year
Secondary	Total body clearance(CL)		through study completion, an average of 1 year
Secondary	Apparent volume of distribution(Vd)		through study completion, an average of 1 year
Secondary	Tumor response rate		through study completion, an average of 1 year
Secondary	Duration of response		through study completion, an average of 1 year
Secondary	Time to progression		through study completion, an average of 1 year
Secondary	Progression free survival		through study completion, an average of 1 year