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A First-in-Human Single Ascending Dose Study of TRX518 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies

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Trial Information

A First-in-Human Single Ascending Dose Study of TRX518 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies


The following visits are required:

- Screening visit: 1 to 2 appointments will be conducted to determine eligibility. All or
most requirements can be determined from the patient's medical records.

- Baseline visit: within 7 days of the planned study dosing day a baseline physical exam,
blood tests and electrocardiogram will be obtained.

- Dosing visit: 1 outpatient visit where TRX518 will be given IV over 1 hour followed by
4 hours of observation and some repeat blood tests.

- Follow up visits: 5 outpatient visits following dosing at 1, 8 and 15 days and 3, 6,
12, and 18 weeks post dosing

- Long term follow-up: 4 brief assessments by medical record review and/or telephone
contact at 6, 12, 18, and 24 months post dosing.

- The core study duration is 18 weeks. The follow-up study duration is 24 months.


Inclusion Criteria:



- 18 years or older at the time of dose initiation.

- Unresectable Stage III or Stage IV biopsy proven malignant melanoma or other solid
tumor 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.

- Karnofsky Performance Status ≥70 in the 7 day baseline period immediately prior to
dosing.

- 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:

- Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS
metastases within 30 days prior to dosing.

- Ocular melanoma.

- Any major surgery within 6 weeks prior to dosing.

- Any history of antitumor therapy (standard or experimental) completed within 30 days
prior to dosing.

- Any concomitant serious physical illness other than cancer (i.e., immune deficiency
disease, bleeding disorder, etc.) within 1 year prior to dosing. Specifically, no
history of autoimmune disease.

- Clinically significant heart disease, defined as NYHA Class III or IV.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1. Adverse events (Safety)

Outcome Description:

Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal.

Outcome Time Frame:

18 weeks

Safety Issue:

Yes

Principal Investigator

Principle Investigator: Jedd Wolchok, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

TRX518-001

NCT ID:

NCT01239134

Start Date:

October 2010

Completion Date:

December 2014

Related Keywords:

  • Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies
  • Malignant melanoma
  • Metastatic
  • Unresectable
  • Stage III or Stage IV
  • Solid tumor
  • Neoplasms
  • Melanoma

Name

Location

Melanoma and Sarcoma Service / Memorial Sloan Kettering Cancer Center New York, New York  10065