Locally Advanced or Metastatic Solid Carcinomas, Colon Cancer, Cholangiocarcinoma
Conditions
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.
Interventions
BIOLOGICALTRK-950
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
Sponsors
Toray Industries, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical laboratory tests | 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 |
| Adverse event | through study completion, an average of 1 year |
| CTCAE version 4.03 | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Area under the concentration curve(AUC) | through study completion, an average of 1 year |
Countries
France, United States
Outcome results
None listed