Advanced Pancreatic CancerPhase 1NCT02101580
Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer
A Phase 1 study testing ADI-PEG 20 in people with Advanced Pancreatic Cancer, run by Polaris Group at 1 site in United States.
Trial summary
Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in subjects with Advanced Pancreatic Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- ADI-PEG 20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2014to 6 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of pancreatic carcinoma (dose escalation and MTD expansion components).
- 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.
- Unresectable disease or subject refused surgery.
- 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.
- Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
- Age ≥ 18 years.
- ECOG performance status of 0 - 1.
- 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.
Who cannot join
- 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.
- Serious underlying lung function abnormality due to the risk of fatal pneumonitis that was caused by the combination of Abraxane and gemcitabine
- Grade 2 or higher neuropathy (CTCAE V4.0)
- Prior treatment with nab-paclitaxel.
- Pregnancy or lactation.
- Expected non-compliance.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- ADI-PEG 20
- Keywords
- argininosuccinate synthetase, arginine, arginine deiminase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-PEG 20Drug
| Study group | Role | What they receive |
|---|---|---|
| ADI-PEG 20 | Experimental | Not described Receives: Drug: ADI-PEG 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: course of study - 1 year expected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study start17 Nov 2014
- Primary completion5 May 2017
- Study completion6 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maeve Lowery, MD, Principal investigator, Memorial Sloan-Kettering Cancer Center (MSKCC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101580
- Sponsor's protocol ID
- POLARIS2013-002
- Status last verified
- Sep 2020
- First submitted
- 25 Mar 2014
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B Trial of ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02101580
- Acronym / sponsor ID
- POLARIS2013-002
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- argininosuccinate synthetase, arginine, arginine deiminase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Polaris GroupIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in subjects with Advanced Pancreatic Carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADI-PEG 20 | Experimental | Drug: ADI-PEG 20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed diagnosis of pancreatic carcinoma (dose escalation and MTD expansion components).
- 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.
- Unresectable disease or subject refused surgery.
- 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.
- Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
Key exclusion criteria (8 listed)
- 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.
- Serious underlying lung function abnormality due to the risk of fatal pneumonitis that was caused by the combination of Abraxane and gemcitabine
- Grade 2 or higher neuropathy (CTCAE V4.0)
- Prior treatment with nab-paclitaxel.
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-PEG 20 | Drug | ADI-PEG 20 |
Primary outcome
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
Time frame: course of study - 1 year expected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
Related trials for Advanced Pancreatic Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maeve Lowery, MD principal investigator
Memorial Sloan-Kettering Cancer Center (MSKCC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADI-PEG 20 in people with Advanced Pancreatic Cancer, run by Polaris Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: course of study - 1 year expected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.