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
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
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Adverse event
Secondary Outcome
Area under the concentration curve(AUC)
Condition
Locally Advanced or Metastatic Solid Carcinomas
Intervention
TRK-950
Study Arms / Comparison Groups
Arm 1 - TRK-950
Description: Solid tumor TRK-950 (Three dose levels will be explored during Arm 1)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
38
Start Date
March 6, 2017
Completion Date
September 16, 2019
Primary Completion Date
September 16, 2019
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02990481
Organization ID
950P1V01
Responsible Party
Sponsor
Study Sponsor
Toray Industries, Inc
Study Sponsor
, ,
Verification Date
November 2020