A Study of TRK-950 in Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
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To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
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To establish the dose of TRK-950 recommended for future phase 2 studies
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 - TRK-950 Solid tumor TRK-950 (Three dose levels will be explored during Arm 1) |
Biological: TRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
|
| Experimental: Arm 2 - TRK-950 Colon cancer TRK-950 (Low dose and High dose) |
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 Cholangiocarcinomas TRK-950 (Low dose) |
Biological: TRK-950
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
|
Outcome Measures
Primary Outcome Measures
- Adverse event [through study completion, an average of 1 year]
- CTCAE version 4.03 [through study completion, an average of 1 year]
- Blood pressure (mmHg) [through study completion, an average of 1 year]
- Heart rate (bpm) [through study completion, an average of 1 year]
- Respiratory rate (bpm) [through study completion, an average of 1 year]
- Temperature (°F or °C) [through study completion, an average of 1 year]
- Weight (lbs/kg) [through study completion, an average of 1 year]
- Height (inches/cm) [through study completion, an average of 1 year]
- Karnofsky performance status [through study completion, an average of 1 year]
- Electrocardiogram [through study completion, an average of 1 year]
- Clinical laboratory tests [through study completion, an average of 1 year]
Secondary Outcome Measures
- Area under the concentration curve(AUC) [through study completion, an average of 1 year]
- Maximum plasma concentration(Cmax) [through study completion, an average of 1 year]
- Time to maximum plasma concentration(Tmax) [through study completion, an average of 1 year]
- Terminal elimination half life(t1/2) [through study completion, an average of 1 year]
- Total body clearance(CL) [through study completion, an average of 1 year]
- Apparent volume of distribution(Vd) [through study completion, an average of 1 year]
- Tumor response rate [through study completion, an average of 1 year]
- Duration of response [through study completion, an average of 1 year]
- Time to progression [through study completion, an average of 1 year]
- Progression free survival [through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with histologically confirmed locally advanced or metastatic solid carcinomas in Arm 1
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Patients with histologically confirmed locally advanced or metastatic colon cancer in Arm 2
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Patients with histologically confirmed locally advanced or metastatic cholangiocarcinomas in Arm 3
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Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy or not amendable to a curative treatment
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Measurable disease per RECIST 1.1 (primary or metastases)
Exclusion Criteria:
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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
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Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
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Pregnant or nursing women
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Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or investigational therapy within four weeks prior to study entry
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Unwillingness or inability to comply with procedures required in this protocol
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Known active infection with HIV, hepatitis B, hepatitis C
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Symptomatic brain metastases
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Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
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Patients who are currently receiving any other investigational agent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Phoenix | Arizona | United States | 85054 |
| 2 | HonorHealth Research Institute | Scottsdale | Arizona | United States | 85258 |
| 3 | Centre Léon Bérard | Lyon | France | 69373 |
Sponsors and Collaborators
- Toray Industries, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 950P1V01