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Dose Escalation Study of TRX518 in Adults With Advanced Solid Tumors

This study is currently recruiting participants.
Verified February 2017 by Leap Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02628574
First Posted: December 11, 2015
Last Update Posted: February 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):
Leap Therapeutics, Inc.
December 1, 2015
December 11, 2015
February 14, 2017
December 2015
February 2018   (Final data collection date for primary outcome measure)
Adverse events [ Time Frame: through 30 days post last dose ]
Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal
Same as current
Complete list of historical versions of study NCT02628574 on ClinicalTrials.gov Archive Site
  • TRX518 peak concentration (Cmax) [ Time Frame: various timepoints through 1 week post dose ]
    Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518
  • Time to peak concentration (Tmax) [ Time Frame: various timepoints through 1 week post dose ]
    Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518
  • Area under the curve (AUC) [ Time Frame: various timepoints through 1 week post dose ]
    Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518
  • RECIST assessment for evidence of antitumor activity [ Time Frame: up to 1 year ]
    RECIST assessment to determine effects of TRX518 on solid tumors.
Same as current
Not Provided
Not Provided
 
Dose Escalation Study of TRX518 in Adults With Advanced Solid Tumors
A Two Part, Phase 1, Multicenter, Open-label Study of TRX518 in Adults With Advanced Solid Tumors Part A: A Dose-Escalation Study of Multi-dose TRX518 Monotherapy Part B: An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose
This study will be conducted in 2 parts (Part A and Part B). Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Dose escalation will be performed in Part A. Cycle 1 data from each cohort will be evaluated for safety and dose-limiting toxicities (DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in which a patient is enrolled and cohorts will be dosed consecutively by ascending dose. Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified, an expanded cohort will be enrolled (Part B).
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors
Drug: TRX518
comparison of different (ascending) doses of TRX518 given via IV fusion
Experimental: TRX518
Subjects receive an assigned dose of TRX518 administered intravenously one time per week on a 21-day cycle
Intervention: Drug: TRX518
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
August 2018
February 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced Solid Malignancies with at least 1 measurable lesion, who have failed to respond to or relapsed following standard treatment or who have declined to pursue standard treatment, in otherwise stable health (as confirmed by medical history, physical examination, ECG, and screening laboratory tests).
  • Expected survival of at least 12 weeks after dosing.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Evidence of adequate organ function by standard laboratory tests.
  • All female subjects of child bearing age must be either surgically sterile, postmenopausal for at least 1 year, or using an acceptable method of contraception. Adequate contraception for both male and female subjects must be used from the beginning of the screening period until at least 8 weeks after the last dose of TRX518.

Exclusion Criteria:

  • Hematologic malignancies or multiple myeloma.
  • Known, clinically important cardiac or respiratory disease
  • Any concomitant serious physical illness other than cancer (e.g., immune deficiency disease, bleeding disorder, etc.) within 1 year prior to dosing. No history of autoimmune disease.
  • Active, uncontrolled infections within 7 days of study entry requiring systemic therapy.
  • Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS metastases within 30 days prior to dosing.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Cyndi Sirard, MD (617) 714-0357 CSirard@leaptx.com
Contact: Reena Lynam (617) 665-5206 RLynam@leaptx.com
United States
 
 
NCT02628574
TRX518-003
No
Not Provided
Not Provided
Leap Therapeutics, Inc.
Leap Therapeutics, Inc.
Not Provided
Study Chair: Cyndi Sirard, MD Leap Therapeutics, Inc.
Leap Therapeutics, Inc.
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP