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

NCT03435289 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: GA CPI 613
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer; Metastatic Pancreatic Cancer

Keywords

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• The maximally tolerated dose of CPI 613 combined with Gemcitabine and nab-paclitaxel

  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

  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

  Evaluation at 2 month intervals through study completion from the date of study entry until the date of progression, up to 1 year

Study Arms (1)

CPI-613, Gemcitabine and Nab-paclitaxel

OTHER

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

Interventions

CPI 613 in Combination With Gemcitabine and Nab-paclitaxel DRUG

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

Also known as: Gemcitabine, Nab-paclitaxel, Abraxane, Gemzar

CPI-613, Gemcitabine and Nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Atlantic Health System: lead
• Cornerstone Pharmaceuticals: collaborator

Study Sites (2)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Overlook Medical Center

Summit, New Jersey, 07901, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

devimistat; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Angela T Alistar, MD

  Morristown Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Ginder, BSN, OCN

CONTACT

973-971-6608; nancy.ginder@atlantichealth.org

Rosemary Stefiniw, RN, MS, CCRC

CONTACT

973-971-5990; rosemary.stefiniw@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: February 19, 2018
• Study Start: October 19, 2017
• Primary Completion: November 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)