Clinical Trial: NCT02990481 - My Cancer Genome

NCT02990481

Description:

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

Related Conditions:

Bladder Carcinoma
Cholangiocarcinoma
Colon Carcinoma
Gastric Carcinoma
Malignant Solid Tumor
Ovarian Carcinoma

Recruiting Status:

Completed

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02990481

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: 950P1V01
NCT ID: NCT02990481

Conditions

Locally Advanced or Metastatic Solid Carcinomas
Colon Cancer
Cholangiocarcinoma

Interventions

Drug	Synonyms	Arms
TRK-950		Arm 1 - TRK-950
TRK-950		Arm 2 - TRK-950
TRK-950		Arm 3 -TRK-950

Purpose

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

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.

Trial Arms

Name	Type	Description	Interventions
Arm 1 - TRK-950	Experimental	Solid tumor TRK-950 (Three dose levels will be explored during Arm 1)	TRK-950
Arm 2 - TRK-950	Experimental	Colon cancer TRK-950 (Low dose and High dose)	TRK-950
Arm 3 -TRK-950	Experimental	Cholangiocarcinomas TRK-950 (Low dose)	TRK-950

Eligibility 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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Adverse event
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Area under the concentration curve(AUC)
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Maximum plasma concentration(Cmax)
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Time to maximum plasma concentration(Tmax)
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Terminal elimination half life(t1/2)
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Total body clearance(CL)
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Apparent volume of distribution(Vd)
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Tumor response rate
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Duration of response
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Time to progression
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Measure:	Progression free survival
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:

Details

Phase:	Phase 1
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	Toray Industries, Inc

Last Updated

November 20, 2020

Clinical Trials /

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