Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer

Phase 1B Trial of ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Advanced Pancreatic Cancer

Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in subjects with Advanced Pancreatic Carcinoma.

Study Overview

• Status: Completed
• Conditions: Advanced Pancreatic Cancer
• Intervention / Treatment: Drug: ADI-PEG 20

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of pancreatic carcinoma (dose escalation and MTD expansion components).
2. Subjects in the dose-escalation component can have had up to 1 prior line of systemic therapy. Subjects with pancreatic carcinoma to be enrolled in the MTD expansion cohort must have untreated, measurable metastatic disease. Subjects for the MTD cohort may have received prior adjuvant gemcitabine or fluoropyrimidine based therapy in the adjuvant setting provided more than 6 months has elapsed following completion of adjuvant therapy.
3. Unresectable disease or subject refused surgery.
4. Progressive disease if treated with chemotherapy, radiotherapy, surgery or immuno-therapy. If prior radiation was given, the measurable disease should be outside the radiation port.
5. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
6. Age ≥ 18 years.
7. ECOG performance status of 0 - 1.
8. No prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 4 weeks. Radiation therapy for symptomatic relief is allowed within the last 2 weeks.

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. Serious underlying lung function abnormality due to the risk of fatal pneumonitis that was caused by the combination of Abraxane and gemcitabine
3. Grade 2 or higher neuropathy (CTCAE V4.0)
4. Prior treatment with nab-paclitaxel.
5. Pregnancy or lactation.
6. Expected non-compliance.
7. 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, social situations that would limit compliance with study requirements.
8. 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, including residual neuropathy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADI-PEG 20	Drug: ADI-PEG 20

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with nab-Paclitaxel and Gemcitabine in Advanced Pancreatic Cancer	course of study - 1 year expected

Collaborators and Investigators

• Sponsor: Polaris Group
• Investigators: Principal Investigator: Maeve Lowery, MD, Memorial Sloan-Kettering Cancer Center (MSKCC)

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2014
• Primary Completion (Actual): May 5, 2017
• Study Completion (Actual): October 6, 2017

Study Registration Dates

• First Submitted: March 25, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: arginine; argininosuccinate synthetase; arginine deiminase
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: POLARIS2013-002