Clinical trial NCT02743637: A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
Official title: A Phase 1 Dose Escalation Study of SDX-7320 to Assess the Safety and Tolerability in Patients With Advanced Refractory or Late-Stage Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancy
Advanced Solid Tumors
Neoplasm
Metastasis
Keywords: Cancer
Oncology
Solid Tumors
Phase 1
SDX-7320
SynDevRx
MetAP2
Breast
Post menopausal
Colorectal
Pancreatic
Ovarian
Endometrial
Esophageal
Lung
Renal
Prostate
Liver
Lead sponsor: SynDevRx, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-19
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.

Detailed description: This is a Phase 1 dose escalation study to assess the safety and tolerability of subcutaneously administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.

Once the MTD has been determined up to 12 patients will be treated at this dose level, to further characterize treatment emergent adverse events (TEAEs).

Eligibility criteria: Inclusion Criteria:

* Patients have at least one site of radiographically measurable disease.
* Eastern Cooperative Oncology Group (ECOG) status ≤1.
* Adequate renal and liver functions.
* Life expectancy ≥3 months.

Exclusion Criteria:

* Patients that have undergone organ transplant surgery.
* The patient has a known history of Hepatitis A, B, or C and is on active anti-viral therapy.
* History of gastric bypass surgery or banding procedure.
* Uncontrolled or refractory hypertension: systolic \>180 or diastolic \>110, or hypotension: systolic \<90 or diastolic \<50 despite medical treatment.
* Participation in any other trial of an investigational agent within 30 days prior to first dose of study drug.
* The resting 12-lead electrocardiogram obtained during screening shows QTc (Fridericia correction) ≥470 ms or has a congenital prolonged QT syndrome.

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose
timeFrame: Up to 30 days after last subject enrolled
Secondary outcomes:
measure: Anti-tumor activity
timeFrame: From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks
Other outcomes:
measure: Peak plasma concentration (Cmax) of active moiety SDX7539
timeFrame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose
measure: Area under the plasma concentration curve from zero to infinity AUC (0-inf) active moiety SDX7539
timeFrame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: SynDevRx, Inc.
name: Neal Salomon, MD
role: STUDY_DIRECTOR
References: