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Clinical Trials List

Protocol NumberPOLARIS2013-001
Completed

2019-01-01 - 2025-12-31

Phase I

Terminated12

ICD-10C16

Malignant neoplasm of stomach

ICD-10C22

Malignant neoplasm of liver and intrahepatic bile ducts

Phase 1-2 Study of ADI PEG 20 plus FOLFOX in Subjects with Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma (HCC)

  • Trial Applicant

  • Sponsor

    TDW PHARMACEUTICALS INC.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yee Chao Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Stop recruiting

Audit

None

Principal Investigator 何景良 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 王蒼恩 Digestive System Department
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator 陳彥仰 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 賴冠銘 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Tsai-Sheng Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊再勝、Mengting Peng

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

22 Stop recruiting

Audit

None

Principal Investigator
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

None

Principal Investigator Huey-En Tzeng Division of Hematology & Oncology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Shinn-Cherng Chen Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 王蒼恩 Digestive System Department
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Hepatocellular carcinoma

Objectives

1. The primary objective is: • Objective response rate (ORR), measured by RECIST 1.1 criteria as assessed by blinded independent central review (BICR) 2. The secondary objectives are: • Progression free survival (PFS) • Overall survival (OS) •Duration of response (DoR) • Disease control rate (DCR) • Pharmacodynamics • Pharmacokinetics • Immunogenicity • AFP changes

Test Drug

ADI-PEG20

Active Ingredient

Arginine deiminase conjugated to polyethylene glycol 20,000 mw

Dosage Form

Injection

Dosage

3.5ml/vial; 11.5±1.0mg/ml

Endpoints

1. Primary Endpoint(s): ORR, DoR, DCR, OS, and PFS
2. Safety endpoints: Adverse events and laboratory results

Inclution Criteria

Phase 2 HCC Subjects:
1. Advanced histologically or cytologically proven HCC (except with prior liver
transplantation)
2. Treatment with at least 2 prior systemic therapy regimens.
3. Child-Pugh grade A. Child-Pugh status should be determined based on clinical findings
and laboratory data during the screening period.
4. Measurable disease using RECIST 1.1 criteria. At least 1 measurable lesion must be
present. Subjects who have received local-regional therapies are eligible, provided that
they have either a target lesion which has not been treated with local therapy and/or the target lesion(s) within the field of the local regional therapy has shown an increase of ≥
20% in size. Local-regional therapy must be completed at least 4 weeks prior to the
baseline CT scan.
5. ECOG performance status of 0 - 1.
6. Expected survival of at least 3 months.
7. Age ≥ 18 years.
8. Fully recovered from any prior surgery and no major surgery within 4 weeks of
initiating treatment. Surgery or procedure for placement of vascular access devices is
exempt from this period.
9. Subjects must agree to use at least one form of highly effective contraception (see
Protocol Section 5.3 for approved methods) or agree to refrain from intercourse for the
duration of the study. Contraceptive use must be continued until at least 30 days after
the last administration of ADI-PEG 20 and at least 90 days after the last administration
of FOLFOX. For female subjects, a serum human chorionic gonadotropin (HCG)
pregnancy test must be negative before entry into the study. If HCG pregnancy test is
positive, further evaluation to rule out pregnancy must be performed according to GCP
before this patient is claimed eligible.
10. Informed consent must be obtained prior to study initiation.
11. No concurrent investigational studies are allowed.
12. Total bilirubin < 1.5 x upper limit of normal range.
13. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x
upper limit of normal range.
14. Absolute neutrophil count (ANC) > 1,500/µL.
15. Platelets > 75,000/µL.
16. Serum uric acid ≤ 8 mg/dL (with or without medication control).
17. Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x
the upper limit of normal range, then the creatinine clearance must be ≥ 60 mL/min/1.73
m2 (calculated using the Jelliffe equation: calculated creatinine clearance = 98 - 0.8
[age (yrs.) - 20] /serum creatinine x (0.9 if female).
18. Brain metastases are allowed if well controlled and without seizures.
19. Serum albumin level ≥ 2.8 g/dL.
20. Prothrombin time (PT)-international normalized ratio (INR): PT <6 seconds above
control or INR <1.7. Subjects on Coumadin anti-coagulants are to receive only 1 point
for their INR status.
21. Subjects with active hepatitis B or C on anti-viremic compounds may remain on such
treatment, except for interferon.

Exclusion Criteria

1. Serious infection requiring treatment with systemically administered antibiotics at the
time of study entrance, or an infection requiring systemic antibiotic therapy within 7
days prior to the first dose of study treatment.
2. Pregnancy or lactation.
3. Expected non-compliance.
4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure (New York Heart Association Class III
or IV), cardiac arrhythmia, or psychiatric illness.
5. Subjects who have had any anticancer treatment prior to entering the study and have not
recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible from
the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk
by the Sponsor and investigator may be allowed upon agreement with both.
6. Subjects with history of another primary cancer, including co-existent second
malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b)
curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no
known active disease present or in the opinion of the investigator will not affect patient
outcome.
7. Subjects who had been treated with ADI-PEG 20 previously.
8. History of seizure disorder not related to underlying cancer.
9. Known HIV positivity (testing not required).
10. Known allergy to pegylated compounds.
11. Known allergy to E. coli drug products (such as GMCSF).
12. Known allergy to oxaliplatin or other platinum compounds.
13. Prior grade 2 or higher neuropathy from prior platinum unless neuropathy is currently ≤ grade 1.
14. Contraindications to fluorouracil
a. Subjects with poor nutritional state.
b. Known depressed bone marrow function.
c. Subjects with potentially serious infections.
d. Known allergy to fluorouracil.

The Estimated Number of Participants

  • Taiwan

    180 participants

  • Global

    225 participants

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