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Phase 1 Trial of ADI PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma or Other Argininousccinate Synthetase (ASS) Deficient Advanced Solid Malignancies


Phase 1
18 Years
90 Years
Open (Enrolling)
Both
Argininosuccinate Synthetase Deficient Tumors

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Trial Information

Phase 1 Trial of ADI PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma or Other Argininousccinate Synthetase (ASS) Deficient Advanced Solid Malignancies


Inclusion Criteria:



1. Histologically confirmed diagnosis of advanced solid tumor (dose escalation
component) or metastatic melanoma (uveal or cutaneous) (dose escalation and MTD
expansion components).

2. ASS (argininosuccinate synthetase) deficient tumor.

3. Unresectable disease or patient refused surgery.

4. Progressive disease if treated with chemotherapy, radiotherapy, surgery or
immuno-therapy.

5. Measurable disease as assessed by RECIST 1.1 criteria.

6. Age ≥ 18 years.

7. Karnofsky performance status of ≥ 70.

8. Acceptable hematologic and chemistry laboratory values.

Exclusion Criteria:

1. Serious infection.

2. Pregnancy or lactation.

3. Uncontrolled intercurrent illness.

4. Subjects who have had any anticancer treatment prior to entering the study and have
not recovered to baseline (except alopecia).

5. History of seizure disorder not related to underlying cancer.

6. Known HIV positivity (testing not required).

7. Uncontrolled or progressing CNS metastases.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with adverse events.

Outcome Time Frame:

Course of study.

Safety Issue:

Yes

Principal Investigator

Siqing Fu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

POLARIS2012-005

NCT ID:

NCT01665183

Start Date:

September 2012

Completion Date:

July 2014

Related Keywords:

  • Argininosuccinate Synthetase Deficient Tumors
  • argininosuccinate synthetase
  • arginine
  • arginine deiminase

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096