Efficacy and Safety Study of PBI-05204 in Patients With Stage IV Metastatic Pancreatic Adenocarcinoma

NCT02329717 | Unknown Phase 2 DMC

• 1 other identifier: 2014-4350
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

This study evaluates the efficacy and safety of PBI-05204, an extract of the leaves of Nerium oleander, in patients with Stage IV metastatic pancreatic cancer. All patients will receive PBI-05204.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  4.5 months

Secondary Outcomes (7)

• Time to Progression

  up to 1 year

• Time to Treatment Failure

  up to 1 year

• Progression free survival

  up to 1 year

• Overall response rate

  up to 1 year

• Tumor control rate

  up to 1 year

Study Arms (1)

PBI 05204

EXPERIMENTAL

PBI 05204 capsules dosed at 0.2255 mg/kg/day, continuous dosing

Drug: PBI 05204

Interventions

PBI 05204 DRUG

PBI 05204 daily dosing

PBI 05204

Eligibility Criteria

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

You may qualify if:

• Patient is male or female aged ≥18 years.
• Patient with histologically-confirmed Stage IV malignant metastatic adenocarcinoma of the pancreas; (a) who has relapsed from or is refractory to standard therapy and for whom no therapy exists that would be curative or might provide significant benefit or (b) who are intolerant to or refuse standard chemotherapy and, therefore, for whom experimental therapy is a reasonable option.
• Patient has measurable disease, as determined by the Investigator using RECIST, version 1.1, as determined within 28 days before baseline (C1D1).
• Patient has an ECOG performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), as assessed on C1D1, before the first dose of PBI 05204.
• Patient has a predicted life-expectancy of ≥3 months.
• Patient has adequate bone marrow function defined as:
• Absolute neutrophil count (ANC) (neutrophil and bands) ≥1.5 x 10 \^9/L
• Platelet count ≥100 x10\^9/L
• Hemoglobin ≥9.0 g/dL
• Patient has adequate hepatic function defined as:
• Total bilirubin within normal limits (WNL) for the institution, unless the bilirubin abnormality is considered due to Gilbert's syndrome.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.0 x the institutional upper limit of normal (ULN), or, in patients with known liver metastases, ≤5.0 x the institutional ULN.
• Serum albumin ≥3.0 g/dL.
• Patient has adequate renal function defined as:
• Serum creatinine ≤1.5 the institutional ULN

You may not qualify if:

• Patient has uncontrolled or significant cardiovascular disease, including:
• Myocardial infarction within 6 months before C1D1.
• Uncontrolled angina within 3 months before C1D1.
• Congestive heart failure, defined as New York Heart Association (NYHA) Class II, within 3 months before C1D1 (see Appendix 1).
• Diagnosed or suspected congenital long QT syndrome.
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White \[WPW\] syndrome, or torsade de pointes), or prolonged QTc interval on pre-entry ECG (\>450 msec). If the automated reading is prolonged (i.e., \>450 msec), the ECG should be manually over-read.
• Any history of second- or third-degree heart block. (Patients with pacemakers may be eligible.)
• Heart rate \<50 bpm during screening.
• Uncontrolled hypertension (blood pressure \>160 mmHg systolic and \>100 mmHg diastolic).
• Patient requires the use of concomitant medications that are contraindicated with cardiac glycosides and/or are known to prolong the QT/QTc interval during study participation (see Appendix 2).
• Patient has evidence of uncontrolled malabsorptive diarrhea that would prevent adequate absorption of PBI 05204.
• Patient has dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
• Patient has uncontrolled or severe intercurrent medical condition (including uncontrolled brain metastases). Patients with stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants are allowed provided there is no dose change within 4 weeks before the first dose of PBI 05204, and no anticipated dose change during study participation.
• Patient underwent major surgery within 4 weeks before the first dose of PBI 05204 or received cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) or an investigational drug or device within 4 weeks (6 weeks for mitomycin C, nitrosoureas, and liposomal doxorubicin) or 5 half-lives of that agent (whichever is shorter) before the first dose of PBI 05204. (For agents in which the total of 5 half-lives is \<10 days, there must be a minimum of 10 days between termination of the investigational drug and administration of PBI 05204). Note that prior liver-directed therapies will be permitted (i.e., chemoembolization, radioembolization), as long as target lesions in the liver have demonstrated growth after the liver-directed treatment. Any drug-related toxicity, with the exception of alopecia, should have recovered to ≤ Grade 1.
• If female, patient is pregnant or breast-feeding.

Sponsors & Collaborators

• Phoenix Biotechnology, Inc: lead

Study Sites (5)

Scottsdale Healthcare Hospitals

Scottsdale, Arizona, 85258, United States

Location

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Related Publications (1)

• Roth MT, Cardin DB, Borazanci EH, Steinbach M, Picozzi VJ, Rosemury A, Wadlow RC, Newman RA, Berlin J. A Phase II, Single-Arm, Open-Label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients with Stage IV Metastatic Pancreatic Adenocarcinoma. Oncologist. 2020 Oct;25(10):e1446-e1450. doi: 10.1634/theoncologist.2020-0440. Epub 2020 Jul 2.

  PMID: 32452588 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jordan Berlin, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 1, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

US (5)