Efficacy And Safety Study Of PBI-05204 In Patients With Stage IV Metastatic Pancreatic Adenocarcinoma

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 Plan

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

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-12-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-09-28
First Submitted that Met QC Criteria 2014-12-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-09-29
First Posted (ESTIMATED) 2015-01-01	Results First Posted N/A	Last Verified 2016-09

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PBI 05204 PBI 05204 capsules dosed at 0.2255 mg/kg/day, continuous dosing	DRUG: PBI 05204 PBI 05204 daily dosing

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: PBI 05204

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

DRUG: PBI 05204

PBI 05204 daily dosing

Primary Outcome Measures	Measure Description	Time Frame
overall survival		4.5 months

Secondary Outcome Measures	Measure Description	Time Frame
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
Duration of response		up to 1 year
CA 19-9 response		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.

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:

Absolute neutrophil count (ANC) (neutrophil and bands) ≥1.5 x 10 ^9/L
Platelet count ≥100 x10^9/L
Hemoglobin ≥9.0 g/dL 7. 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. 8. Patient has adequate renal function defined as:

For women: Negative pregnancy test during screening (Day 3 to Day 1) before C1D1 and compliant with a medically-approved contraceptive regimen during and for 3 months after the treatment period or documented to be surgically sterile (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months; or receiving hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level >35 mIU/mL).
For men: Compliant with a medically-approved contraceptive regimen during and for 3 months after the treatment period or documented to be surgically sterile. Men whose sexual partners are of child-bearing potential must agree to use a medically-approved contraceptive regimen during the study and for 3 months after the treatment period. 12. Patient is capable of swallowing study drug capsules whole. 13. Patient is willing and able to participate in the study and comply with all study requirements.

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). 2. 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). 3. Patient has evidence of uncontrolled malabsorptive diarrhea that would prevent adequate absorption of PBI 05204. 4. Patient has dementia or altered mental status that would prohibit the understanding or rendering of informed consent. 5. 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. 6. 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. 7. If female, patient is pregnant or breast-feeding. 8. Patient has evidence of a serious active infection (e.g., infection requiring treatment with intravenous antibiotics). 9. Patient has known human immunodeficiency virus (HIV) or hepatitis B or C infection, as such patients may be at increased risk for toxicity due to concomitant treatment, and disease-related symptoms may preclude accurate assessment of the safety of PBI 05204. 10. Patient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study. 11. Patient has a history of other malignancy treated with curative intent within the previous 5 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with previous invasive cancers are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease. 12. Patient was previously exposed to PBI 05204. 13. Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to PBI-05204 (i.e., cardiac glycoside compounds).

Collaborators and Investigators

Publications

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Resources

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Caregivers

Clinical Trial Record