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Carcinoma, Hepatocellular

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Arginine

Dose: 36 mg/m2 given weekly

Route of Administration: Intramuscular (IM)

In combination with modified FOLFOX6, every 2 weeks, intravenous (IV) / IV bolus

ADI-PEG 20 plus modified FOLFOX6

James Harding, MD

Phase 1: 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: Assessment of the objective response rate (ORR), measured by RECIST 1.1 criteria as assessed by blinded independent central review (BICR).

Phase 1:The primary objective of the dose escalation portion of this study was to assess the safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin (mFOLFOX6) in advanced GI malignancies. The primary objective of the maximum tolerated dose (MTD) expansion phase (recommended phase 2 dose \[RP2D\]) of this study was to determine preliminary estimates of efficacy, measured by RECIST 1.1 criteria, for ADI-PEG 20 in combination with FOLFOX in hepatocellular carcinoma (HCC), gastro-esophageal cancer (GEC), and colorectal cancer (CRC).

Phase 2: The primary objective of this single arm trial is ORR. Based on a two-sided exact test of a one-sample proportion with an alpha of 0.05, under a presumed ORR of 22%, there is 80% power to yield 95% confidence interval of 15-26%, which will require 46 objective responses in 225 subjects. A futility analysis will be described in the Statistical Analysis Plan.

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

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

The percent of subjects who exhibit each level of tumor response, measured by RECIST 1.1 criteria as assessed by blinded independent central review.

Time from the first dose until objective tumor progression or death from any cause

The time from first treatment with ADI-PEG 20 until death or censoring

the time in weeks between the first occurrence of objective response and the development of progressive disease or death

the proportion of subjects at each post-baseline assessment who exhibit tumor response of complete response, partial response or stable disease

Maximal percent changes of AFP during the course of study compared to AFP at baseline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma	NCT02102022	Advanced Gastro... Hepatocellular ... Gastric Cancer Colorectal Canc...	ADI-PEG 20 plus...	18 Years -	Polaris Group
Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma	NCT02102022	Advanced Gastro... Hepatocellular ... Gastric Cancer Colorectal Canc...	ADI-PEG 20 plus...	18 Years -	Polaris Group

Spots Global Cancer Trial Database for advanced gastrointestinal (gi) malignancies