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

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ClinicalTrials.gov Identifier: NCT02743637
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Advanced Malignancy Advanced Solid Tumors Neoplasm Metastasis Drug: SDX-7320 Phase 1

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).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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 ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: April 19, 2016    Key Record Dates
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