Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma

Conditions:Colorectal Cancer, Colorectal Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:November 2014
End Date:October 2019
Contact:John Bomalaski, M.D.

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Phase 1/2 Study of ADI-PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma

Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid
(leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.

Phase 2 HCC Subjects:

Inclusion Criteria:

1. Advanced histologically or cytologically proven HCC (except with prior liver

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 (Appendix C).

4. Measurable disease using RECIST 1.1 criteria (Appendix A). 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 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) > 1500/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:

A subject will not be eligible for study participation if he/she meets any of the exclusion

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

1. Subjects with poor nutritional state.

2. Known depressed bone marrow function.

3. Subjects with potentially serious infections.

4. Known allergy to fluorouracil.
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