A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors



Status:Recruiting
Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - 80
Updated:4/21/2016
Start Date:February 2016
Contact:Neal Salomon, MD
Email:medicalmonitor@syndevrx.com
Phone:(617) 859-6508

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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

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.

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 a total of 12 patients will be treated at this dose level,
to further characterize treatment emergent adverse events (TEAEs).

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
enrollment.

- The resting 12-lead electrocardiogram obtained during screening shows QTc (Bazett's
correction) ≥470 ms or has a congenital prolonged QT syndrome.
We found this trial at
3
sites
Scottsdale, Arizona 85258
Principal Investigator: Hani Babiker, MD
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Monica Mita, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Johanna Bendell, MD
Phone: 615-329-7440
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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