Pancreatic CancerPhase 1NCT03435289
A Study of CPI-613 With Gemcitabine and Nab-paclitaxel for Patients With Advanced or Metastatic Pancreatic Cancer
A Phase 1 study testing CPI 613 in Combination With Gemcitabine and Nab-paclitaxel in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Atlantic Health System at 2 sites in United States.
Trial summary
This is a single arm, open-label study of CPI-613 in combination with gemcitabine and nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer never treated with systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- CPI 613 in Combination With Gemcitabine and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2017to Jan 2019
- 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 documented and measurable stage III or IV pancreatic adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- First line treatment for patients diagnosed with metastatic disease
- First line treatment for patients with locally advanced pancreatic cancer who have not been treated with systemic therapies. Prior treatment with chemoradiation is allowed if 4 or more weeks have passed from completion of chemo-radiotherapy.
- Expected survival > 3 months.
- Women of child-bearing potential must use accepted contraceptive methods (abstinence, intrauterine device, oral contraceptive, or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
Show all 13Show fewer
- Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
- Laboratory values ≤2 weeks must be:
- Adequate hematologic (platelet count ≥ 100,000 cells/mm^3 or ≥ 100 bil/L; absolute neutrophil count [ANC] ≥ 1500 cells/mm3 or ≥1.5 bil/L; and hemoglobin ≥ 9 g/dL or ≥ 90 g/L).
- Adequate hepatic function (aspartate aminotransferase [AST/SGOT] ≤ 3x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] ≤ 3x UNL (≤ 5x UNL if liver metastases present), Total bilirubin ≤ 1.5x ULN C. Adequate renal function (serum creatinine ≤ 2.0 mg/dL or 177 μmol/L). D. Adequate coagulation (International Normalized Ratio or INR must be ≤ 1.5), unless the patient receives anticoagulation treatment in which case the INR should be within the therapeutic level, not higher than 3.5 E. Albumin > 2.5 g/dL
- No evidence of active infection and no serious infection within the past month.
- Mentally competent, ability to understand and willingness to sign the informed consent form.
- -
Who cannot join
- Unwilling or unable to follow protocol requirements. Endocrine or acinar pancreatic carcinoma
- Known cerebral metastases, central nervous system (CNS), or epidural tumor
- Prior treatment with any systemic chemotherapy for metastatic adenocarcinoma of the pancreas or for stage III (locally advanced) adenocarcinoma
- Presence of clinically significant abdominal ascites
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment.
- Serious medical illness that would potentially increase patients' risk for toxicity.
Show all 23Show fewer
- Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
- Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
- Lactating females.
- Fertile men unwilling to practice contraceptive methods during the study period.
- Life expectancy less than 3 months.
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
- Unwilling or unable to follow protocol requirements.
- Active heart disease including but not limited to symptomatic congestive heart failure (NYHA class 3 or 4), symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction.
- Patients with a history of myocardial infarction that is <3 months prior to registration.
- Evidence of active infection, or serious infection within the past month.
- Patients with known HIV infection.
- Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment. Steroid use for contrast induced allergy or other supportive care indication is allowed
- Requirement for immediate palliative treatment of any kind including surgery.
- Any other malignancy within last 3 years
- History of interstitial lung disease, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis
- Peripheral neuropathy grades 2 or higher
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Nancy Ginder, BSN, OCN, 973-971-6608, nancy.ginder@atlantichealth.org
Joshua Strauss, MD
- Recruiting
Overlook Medical Center
Summit, New Jersey, 07901
Christopher Buck, BSN, MS, 908-522-2043, christopher.buck@atlantichealth.org
Sophie D Morse, MD
About this study
Official title: A Phase I Study of CPI-613 in Combination With Gemcitabine and Nab-paclitaxel (Abraxane) for Patients With Locally Advanced or Metastatic Pancreatic Cancer
This is a single arm, open-label study of CPI-613 in combination with gemcitabine and nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer never treated with systemic chemotherapy.
Read the detailed description
The primary specific aim of the study is to establish the maximum tolerated dose (MTD) of CPI-613 when given in combination with gemcitabine/nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer.
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Being tested
- CPI 613 in Combination With Gemcitabine and Nab-paclitaxel
- Keywords
- Advanced Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI 613 in Combination With Gemcitabine and Nab-paclitaxelDrug
Also called Gemcitabine, Nab-paclitaxel, Abraxane, Gemzar
Day 1,15 CPI-613: IV infusion at a rate of 4 mL/min via a central venous catheter starting at 500 mg/m2 (with concurrent D5W infusing at a rate of 125-150 cc/hr). The CPI dose will be determined based on cohort. Day 2,16 Neulasta as clinically indicated
Nab- paclitaxel 125mg/m2 iv over 30 min followed by Gemcitabine 1000mg/m2 iv over 30 min
| Study group | Role | What they receive |
|---|---|---|
| CPI-613, Gemcitabine and Nab-paclitaxel | Other | CPI-613 in Combination With Gemcitabine 1000mg/m2 iv and Nab-paclitaxel 125mg/m2 iv Receives: Drug: CPI 613 in Combination With Gemcitabine and Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximally tolerated dose of CPI 613 combined with Gemcitabine and nab-paclitaxel
Measured: Evaluation at monthly intervals through study completion from the date of study entry until the date of progression, up to 1 year
Secondary outcomes (2)
The number of participants with treatment related adverse events as assessed by CTCAE v 4.0
Measured: Evaluation at 2 week intervals through study completion from the date of study entry until the date of progression, up to 1 year
The number of participants with complete or partial response
Measured: Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start19 Oct 2017
- Primary completionNov 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- This is a single arm, open-label study of CPI-613 in combination with gemcitabine and nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Cornerstone Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Angela T Alistar, MD, Principal investigator, Morristown Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435289
- Sponsor's protocol ID
- GA CPI 613
- Status last verified
- Feb 2018
- First submitted
- 17 Nov 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of CPI-613 in Combination With Gemcitabine and Nab-paclitaxel (Abraxane) for Patients With Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03435289
- Acronym / sponsor ID
- GA CPI 613
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer
- Keywords
- Advanced Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Collaborators
- Cornerstone Pharmaceuticals
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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.
This is a single arm, open-label study of CPI-613 in combination with gemcitabine and nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer never treated with systemic chemotherapy.
Detailed description
The primary specific aim of the study is to establish the maximum tolerated dose (MTD) of CPI-613 when given in combination with gemcitabine/nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm, open-label study of CPI-613 in combination with gemcitabine and nab-paclitaxel for patients with locally advanced or metastatic pancreatic cancer
| Arm | Type | Receives |
|---|---|---|
| CPI-613, Gemcitabine and Nab-paclitaxel | Other | Drug: CPI 613 in Combination With Gemcitabine and Nab-paclitaxelCPI-613 in Combination With Gemcitabine 1000mg/m2 iv and Nab-paclitaxel 125mg/m2 iv |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically documented and measurable stage III or IV pancreatic adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- First line treatment for patients diagnosed with metastatic disease
- First line treatment for patients with locally advanced pancreatic cancer who have not been treated with systemic therapies. Prior treatment with chemoradiation is allowed if 4 or more weeks have passed from completion of chemo-radiotherapy.
- Expected survival > 3 months.
Key exclusion criteria (23 listed)
- Unwilling or unable to follow protocol requirements. Endocrine or acinar pancreatic carcinoma
- Known cerebral metastases, central nervous system (CNS), or epidural tumor
- Prior treatment with any systemic chemotherapy for metastatic adenocarcinoma of the pancreas or for stage III (locally advanced) adenocarcinoma
- Presence of clinically significant abdominal ascites
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment.
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 |
|---|---|---|
| CPI 613 in Combination With Gemcitabine and Nab-paclitaxelAlso: Gemcitabine, Nab-paclitaxel, Abraxane, GemzarDay 1,15 CPI-613: IV infusion at a rate of 4 mL/min via a central venous catheter starting at 500 mg/m2 (with concurrent D5W infusing at a rate of 125-150 cc/hr). The CPI dose will be determined based on cohort. Day 2,16 Neulasta as clinically indicated Nab- paclitaxel 125mg/m2 iv over 30 min followed by Gemcitabine 1000mg/m2 iv over 30 min | Drug | CPI-613, Gemcitabine and Nab-paclitaxel |
Primary outcome
The maximally tolerated dose of CPI 613 combined with Gemcitabine and nab-paclitaxel
Time frame: Evaluation at monthly intervals through study completion from the date of study entry until the date of progression, up to 1 year
2 secondary outcomes
The number of participants with treatment related adverse events as assessed by CTCAE v 4.0
Time frame: Evaluation at 2 week intervals through study completion from the date of study entry until the date of progression, up to 1 year
The number of participants with complete or partial response
Time frame: Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No. There is no plan to make individual data available to other researchers
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Angela T Alistar, MD principal investigator
Morristown Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPI 613 in Combination With Gemcitabine and Nab-paclitaxel in people with Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Atlantic Health System at 2 sites 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 13 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy Ginder, BSN, OCN (973-971-6608, nancy.ginder@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximally tolerated dose of CPI 613 combined with Gemcitabine and nab-paclitaxel (time frame: Evaluation at monthly intervals through study completion from the date of study entry until the date of progression, up to 1 year). 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 19 Feb 2018.