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Clinical Trial Record

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A Study of CPI-613 With Gemcitabine and Nab-paclitaxel for Patients With Advanced or Metastatic Pancreatic Cancer

2017-10-19

2018-11

2019-01

24

Study Overview

A Study of CPI-613 With Gemcitabine and Nab-paclitaxel for Patients With 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.

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.

  • Pancreatic Cancer
  • Metastatic Pancreatic Cancer
  • DRUG: CPI 613 in Combination With Gemcitabine and Nab-paclitaxel
  • GA CPI 613

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2017-11-17  

N/A  

2018-02-09  

2018-02-09  

N/A  

2018-02-19  

2018-02-19  

N/A  

2018-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
OTHER: CPI-613, Gemcitabine and Nab-paclitaxel

CPI-613 in Combination With Gemcitabine 1000mg/m2 iv and Nab-paclitaxel 125mg/m2 iv

DRUG: CPI 613 in Combination With Gemcitabine and Nab-paclitaxel

  • 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
Primary Outcome MeasuresMeasure DescriptionTime Frame
The maximally tolerated dose of CPI 613 combined with Gemcitabine and nab-paclitaxelEvaluation at monthly intervals through study completion from the date of study entry until the date of progression, up to 1 year
Secondary Outcome MeasuresMeasure DescriptionTime Frame
The number of participants with treatment related adverse events as assessed by CTCAE v 4.0Evaluation 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 responseEvaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nancy Ginder, BSN, OCN

Phone Number: 973-971-6608

Email: nancy.ginder@atlantichealth.org

Study Contact Backup

Name: Rosemary Stefiniw, RN, MS, CCRC

Phone Number: 973-971-5990

Email: rosemary.stefiniw@atlantichealth.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Histologically or cytologically documented and measurable stage III or IV pancreatic adenocarcinoma. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 3. First line treatment for patients diagnosed with metastatic disease 4. 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. 5. Expected survival > 3 months. 6. 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. 7. Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists. 8. Laboratory values ≤2 weeks must be:
    A. 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).
    B. 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 9. No evidence of active infection and no serious infection within the past month. 10. Mentally competent, ability to understand and willingness to sign the informed consent form.
    -
    Exclusion Criteria:
    1. Unwilling or unable to follow protocol requirements. Endocrine or acinar pancreatic carcinoma 2. Known cerebral metastases, central nervous system (CNS), or epidural tumor 3. Prior treatment with any systemic chemotherapy for metastatic adenocarcinoma of the pancreas or for stage III (locally advanced) adenocarcinoma 4. Presence of clinically significant abdominal ascites 5. 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. 6. Serious medical illness that would potentially increase patients' risk for toxicity. 7. Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease). 8. Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown). 9. Lactating females. 10. Fertile men unwilling to practice contraceptive methods during the study period. 11. Life expectancy less than 3 months. 12. Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients. 13. Unwilling or unable to follow protocol requirements. 14. 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. 15. Patients with a history of myocardial infarction that is <3 months prior to registration. 16. Evidence of active infection, or serious infection within the past month. 17. Patients with known HIV infection. 18. 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 19. Requirement for immediate palliative treatment of any kind including surgery. 20. Any other malignancy within last 3 years 21. History of interstitial lung disease, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis 22. Peripheral neuropathy grades 2 or higher
    -

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Cornerstone Pharmaceuticals
  • PRINCIPAL_INVESTIGATOR: Angela T Alistar, MD, Morristown Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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