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

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ClinicalTrials.gov Identifier: NCT03435289
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
Rafael Pharmaceuticals Inc.
Information provided by (Responsible Party):
Atlantic Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Metastatic Pancreatic Cancer Drug: CPI 613 in Combination With Gemcitabine and Nab-paclitaxel Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Nab- paclitaxel 125mg/m2 iv over 30 min followed by Gemcitabine 1000mg/m2 iv over 30 min

Other Names:
  • Gemcitabine
  • Nab-paclitaxel
  • Abraxane
  • Gemzar




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435289


Contacts
Contact: Nancy Ginder, BSN, OCN 973-971-6608 nancy.ginder@atlantichealth.org
Contact: Rosemary Stefiniw, RN, MS, CCRC 973-971-5990 rosemary.stefiniw@atlantichealth.org

Locations
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Nancy Ginder, BSN, OCN    973-971-6608    nancy.ginder@atlantichealth.org   
Sub-Investigator: Joshua Strauss, MD         
Principal Investigator: Angela T Alistar, MD         
Overlook Medical Center Recruiting
Summit, New Jersey, United States, 07901
Contact: Christopher Buck, BSN, MS    908-522-2043    christopher.buck@atlantichealth.org   
Sub-Investigator: Sophie D Morse, MD         
Sponsors and Collaborators
Atlantic Health System
Rafael Pharmaceuticals Inc.
Investigators
Principal Investigator: Angela T Alistar, MD Morristown Medical Center

Responsible Party: Atlantic Health System
ClinicalTrials.gov Identifier: NCT03435289     History of Changes
Other Study ID Numbers: GA CPI 613
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual data available to other researchers

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atlantic Health System:
Advanced Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs