A Study of TRK-950 in Patients With Advanced Solid Tumors
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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
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- 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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Locally Advanced or Metastatic Solid Carcinomas Colon Cancer Cholangiocarcinoma | Biological: TRK-950 | Phase 1 |
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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 - TRK-950
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Biological: TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle |
Experimental: Arm 2 - TRK-950
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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
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Biological: TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle |
- Adverse event [ Time Frame: through study completion, an average of 1 year ]
- CTCAE version 4.03 [ Time Frame: through study completion, an average of 1 year ]
- Blood pressure (mmHg) [ Time Frame: through study completion, an average of 1 year ]
- Heart rate (bpm) [ Time Frame: through study completion, an average of 1 year ]
- Respiratory rate (bpm) [ Time Frame: through study completion, an average of 1 year ]
- Temperature (°F or °C) [ Time Frame: through study completion, an average of 1 year ]
- Weight (lbs/kg) [ Time Frame: through study completion, an average of 1 year ]
- Height (inches/cm) [ Time Frame: through study completion, an average of 1 year ]
- Karnofsky performance status [ Time Frame: through study completion, an average of 1 year ]
- Electrocardiogram [ Time Frame: through study completion, an average of 1 year ]
- Clinical laboratory tests [ Time Frame: through study completion, an average of 1 year ]
- Area under the concentration curve(AUC) [ Time Frame: through study completion, an average of 1 year ]
- Maximum plasma concentration(Cmax) [ Time Frame: through study completion, an average of 1 year ]
- Time to maximum plasma concentration(Tmax) [ Time Frame: through study completion, an average of 1 year ]
- Terminal elimination half life(t1/2) [ Time Frame: through study completion, an average of 1 year ]
- Total body clearance(CL) [ Time Frame: through study completion, an average of 1 year ]
- Apparent volume of distribution(Vd) [ Time Frame: through study completion, an average of 1 year ]
- Tumor response rate [ Time Frame: through study completion, an average of 1 year ]
- Duration of response [ Time Frame: through study completion, an average of 1 year ]
- Time to progression [ Time Frame: through study completion, an average of 1 year ]
- Progression free survival [ Time Frame: through study completion, an average of 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cholangiocarcinoma Neoplasms Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |