We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors (SDX-0101)

This study is currently recruiting participants.
Verified August 2016 by SynDevRx, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02743637
First Posted: April 19, 2016
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
SynDevRx, Inc.
  Purpose
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.

Condition Intervention Phase
Advanced Malignancy Advanced Solid Tumors Neoplasm Metastasis Drug: SDX-7320 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by SynDevRx, Inc.:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose [ Time Frame: Up to 30 days after last subject enrolled ]

Secondary Outcome Measures:
  • Anti-tumor activity [ Time Frame: From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks ]
    RECIST v1.1


Other Outcome Measures:
  • Peak plasma concentration (Cmax) of active moiety SDX7539 [ Time Frame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose ]
  • Area under the plasma concentration curve from zero to infinity AUC (0-inf) active moiety SDX7539 [ Time Frame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose ]

Estimated Enrollment: 30
Actual Study Start Date: February 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SDX-7320
Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined.
Drug: SDX-7320
SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743637


Contacts
Contact: Neal Salomon, MD (617) 859-6508 medicalmonitor@syndevrx.com

Locations
United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer    480-323-1339 ext 2    clinicaltrials@honorhealth.com   
Principal Investigator: Michael Gordon, MD         
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Nia Harmon    310-967-8594    Nia.Harmon@cshs.org   
Principal Investigator: Monica Mita, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: AskSarah    615-339-4214      
Principal Investigator: Johanna Bendell, MD         
Sponsors and Collaborators
SynDevRx, Inc.
Investigators
Study Director: Neal Salomon, MD SynDevRx, Inc.
  More Information

Additional Information:
Responsible Party: SynDevRx, Inc.
ClinicalTrials.gov Identifier: NCT02743637     History of Changes
Other Study ID Numbers: SDX-0101
First Submitted: April 7, 2016
First Posted: April 19, 2016
Last Update Posted: April 14, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by SynDevRx, Inc.:
SDX-7320
Cancer
Oncology
Solid Tumors
Phase 1
SynDevRx
MetAP2
Breast
Post menopausal
Colorectal
Pancreatic
Ovarian
Endometrial
Esophageal
Lung
Renal
Prostate
Liver


To Top