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Pancreatic CancerPhase 2NCT02329717

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

A Phase 2 study testing PBI 05204 in people with Pancreatic Cancer, run by Phoenix Biotechnology, Inc at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
PBI 05204
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
5 sitesUnited States
Study dates
Apr 2015to Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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
  • Patient has serum potassium and magnesium levels WNL for the institution and total serum calcium or ionized calcium levels ≥ the lower limit of normal (LLN). Patients with low potassium, calcium, and/or magnesium levels may receive supplementation to meet the protocol entry criteria. (Calcium supplementation is prohibited after starting PBI-05204; see Appendix 2.)
  • Patient provides signed and dated informed consent prior to initiation of any study procedures.
  • Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last dose of PBI 05204, as follows:
  • 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.
  • Patient is capable of swallowing study drug capsules whole.
  • Patient is willing and able to participate in the study and comply with all study requirements.

Who cannot join

  • 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.
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  • 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.
  • Patient has evidence of a serious active infection (e.g., infection requiring treatment with intravenous antibiotics).
  • 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.
  • 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.
  • 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.
  • Patient was previously exposed to PBI 05204.
  • Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to PBI-05204 (i.e., cardiac glycoside compounds).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Scottsdale Healthcare Hospitals

    Scottsdale, Arizona, 85258

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Florida Hospital Tampa

    Tampa, Florida, 33613

Other trials in United States

About this study

Official title: A Phase II, Single-arm, Open-label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients With Stage IV Metastatic Pancreatic Adenocarcinoma

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.

Being tested
PBI 05204
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PBI 05204Drug

    PBI 05204 daily dosing

Study groups in NCT02329717
Study groupRoleWhat they receive
PBI 05204ExperimentalPBI 05204 capsules dosed at 0.2255 mg/kg/day, continuous dosing
Receives: Drug: PBI 05204

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: 4.5 months

Secondary outcomes (7)

  1. Time to Progression

    Measured: up to 1 year

  2. Time to Treatment Failure

    Measured: up to 1 year

  3. Progression free survival

    Measured: up to 1 year

  4. Overall response rate

    Measured: up to 1 year

  5. Tumor control rate

    Measured: up to 1 year

  6. Duration of response

    Measured: up to 1 year

  7. CA 19-9 response

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02329717
Sponsor's protocol ID
2014-4350
Status last verified
Sep 2016
First submitted
23 Dec 2014
Last updated
29 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32452588

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PBI 05204 in people with Pancreatic Cancer, run by Phoenix Biotechnology, Inc at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 4.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02329717, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.

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