Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02101580
Other study ID # POLARIS2013-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 17, 2014
Est. completion date October 6, 2017

Study information

Verified date September 2020
Source Polaris Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date October 6, 2017
Est. primary completion date May 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
ADI-PEG 20


Locations

Country Name City State
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Polaris Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05028933 - IMC001 for Clinical Research on Advanced Digestive System Malignancies Phase 1
Not yet recruiting NCT03662035 - Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer Phase 2
Recruiting NCT05085548 - ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies Phase 1
Recruiting NCT06111274 - A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT04137536 - A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer Phase 1
Completed NCT04617067 - Paricalcitol Trial: Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT04469556 - Pancreatic Adenocarcinoma Signature Stratification for Treatment Phase 2
Recruiting NCT04104672 - A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies Phase 1
Not yet recruiting NCT05100329 - A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer Phase 2
Not yet recruiting NCT06329947 - A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD Phase 2
Recruiting NCT02135822 - Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer Phase 2
Recruiting NCT04803851 - Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT03415802 - Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer Phase 2
Recruiting NCT05162118 - Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer Phase 1/Phase 2
Recruiting NCT04643405 - APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma Phase 1/Phase 2
Recruiting NCT03889795 - Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors Phase 1
Completed NCT01303172 - A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer Phase 2
Not yet recruiting NCT06422156 - SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer Phase 2
Recruiting NCT04931381 - Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer Phase 3
Recruiting NCT04482257 - Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer. Phase 1