Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD)

NCT03415854 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SU2C HRI NPG-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the combination of paclitaxel protein bound, gemcitabine, cisplatin, paricalcitol are effective in individuals with previously untreated metastatic pancreatic cancer.

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Pancreas Metastases; Pancreatic Adenocarcinoma; Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Best Overall Response (BOR)

  Best overall response (BOR) is defined as the best tumor response recorded 9 weeks after treatment initiation Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1). Responses are categorized as: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; stable disease (SD), no change in target lesion size; and progressive disease (PD), ≥20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. MRI completed every 3 cycles of treatment to determine if the tumor responded to treatment. A confirmatory positron emission tomography (PET) scan could be ordered to confirm CR.

  From enrollment until the end of 3+ treatment cycles (each cycle is 21 days), up to 190 days.

• Progression-free Survival (PFS)

  Progression-free survival (PFS) is defined as the time from starting paricalcitol until disease progression. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a ≥20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.

  From start of paricalcitol to disease progression, up to 7 months

• Overall Survival (OS)

  Overall survival (OS) is defined as the length of time that patients remained alive after starting paricalcitol treatment.

  From start of paricalcitol through follow-up, up to 16.5 months

Secondary Outcomes (2)

• Serum Levels of Carbohydrate Antigen 19-9 (CA19-9)

  At the end of each treatment cycle (each cycle is 21 days), up to 30 weeks.

• Adverse Events Possibly Related to Paricalcitol

  From enrollment through 30 days after last paricalcitol treatment, up to 16.5 months

Study Arms (1)

Paricalcitol (Zemplar)

EXPERIMENTAL

Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any.

Drug: Paricalcitol (Zemplar)

Interventions

Paricalcitol (Zemplar) DRUG

combination therapy

Also known as: Cisplatin (Platinol), Paclitaxel Protein Bound (Abraxane), Gemcitabine (Gemzar)

Paricalcitol (Zemplar)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years of age; male or female.
• Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
• Capable of providing informed consent and complying with trial procedures including obtaining paired biopsies during therapy
• Karnofsky Performance Status (KPS) of ≥ 70%.
• Life expectancy ≥ 12 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.
• Women must agree not to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study and until 90 days after last dose of study treatment. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.

You may not qualify if:

• Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
• Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
• Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
• Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
• History of other malignancies (except cured basal or squamous cell carcinoma, superficial bladder cancer, prostate cancer in active surveillance, or carcinoma in situ of the cervix) unless documented free of cancer for ≥2 years.
• Laboratory values: Screening serum creatinine \>1.5 mg/dL; total bilirubin \> (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5x ULN or ≥ 5.0×ULN if liver metastases are present; absolute neutrophil count \<1,500/mm3, platelet concentration \<100,000/mm3, hematocrit level \<27% for females or \<30% for males, or coagulation tests (prothrombin time \[PT\], partial thromboplastin time \[PTT\], International Normalized Ratio \[INR\]) \>1.5×ULN unless on anticoagulation agents.
• Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
• History of HIV infection.
• Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or anti-fungals.
• Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.

Sponsors & Collaborators

• HonorHealth Research Institute: lead
• Barts Cancer Institute: collaborator
• Mayo Clinic: collaborator
• Abramson Cancer Center at Penn Medicine: collaborator
• Salk Institute for Biological Studies: collaborator
• Princeton University: collaborator
• Imaging Endpoints: collaborator
• Translational Genomics Research Institute: collaborator
• Stand Up To Cancer: collaborator
• Cancer Research UK: collaborator
• Lustgarten Foundation: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

paricalcitol; Cisplatin; Taxes; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Limitations of this study include the small sample size, lack of dose escalation, and no placebo control group. Furthermore, exploratory analyses of tumor tissue samples and some circulating markers were unable to be completed due to impacts from the COVID-19 pandemic, limiting our ability to understand if there were any molecular or structural changes to the TME with paricalcitol treatment or systemic pathway impacts.

Results Point of Contact

• Title: Erkut Borazanci, MD
• Organization: HonorHealth Research Institute

eborazanci@honorhealth.com

480-583-7120

Study Officials

• Erkut Borazanci, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 30, 2018
• Study Start: January 31, 2018
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: To be determined
• Access Criteria: The Investigator and any other study personnel involved in this study shall not disclose, or use for any purposes (other than for the performance of this study), any data, records, or other information (hereinafter collectively "information") disclosed to the Investigator or other study personnel. Such information shall remain the confidential and proprietary property of HonorHealth, and shall be disclosed only to the Investigator or other designated study personnel. The obligation of non-disclosure shall not apply to the following: * relevant disclosure to potential study participants for the purpose of obtaining informed consent; * information after such time that it is or becomes publicly available through no fault of the Investigator or other study personnel; and, * information after such time that it is disclosed to the Investigator by a third party entitled to disclose such information.

Locations

US (1)