Clinical trial NCT02990481: A Phase 1 Study Evaluating the Safety 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Solid Carcinomas
Colon Cancer
Cholangiocarcinoma
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse event
timeFrame: through study completion, an average of 1 year
measure: CTCAE version 4.03
timeFrame: through study completion, an average of 1 year
measure: Blood pressure (mmHg)
timeFrame: through study completion, an average of 1 year
measure: Heart rate (bpm)
timeFrame: through study completion, an average of 1 year
measure: Respiratory rate (bpm)
timeFrame: through study completion, an average of 1 year
measure: Temperature (°F or °C)
timeFrame: through study completion, an average of 1 year
measure: Weight (lbs/kg)
timeFrame: through study completion, an average of 1 year
measure: Height (inches/cm)
timeFrame: through study completion, an average of 1 year
measure: Karnofsky performance status
timeFrame: through study completion, an average of 1 year
measure: Electrocardiogram
timeFrame: through study completion, an average of 1 year
measure: Clinical laboratory tests
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Area under the concentration curve(AUC)
timeFrame: through study completion, an average of 1 year
measure: Maximum plasma concentration(Cmax)
timeFrame: through study completion, an average of 1 year
measure: Time to maximum plasma concentration(Tmax)
timeFrame: through study completion, an average of 1 year
measure: Terminal elimination half life(t1/2)
timeFrame: through study completion, an average of 1 year
measure: Total body clearance(CL)
timeFrame: through study completion, an average of 1 year
measure: Apparent volume of distribution(Vd)
timeFrame: through study completion, an average of 1 year
measure: Tumor response rate
timeFrame: through study completion, an average of 1 year
measure: Duration of response
timeFrame: through study completion, an average of 1 year
measure: Time to progression
timeFrame: through study completion, an average of 1 year
measure: Progression free survival
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
References: