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Pancreatic Neuroendocrine CancerPhase 2PALBONETNCT02806648

A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)

A Phase 2 study testing Palbociclib in people with Pancreatic Neuroendocrine Cancer, run by Grupo Espanol de Tumores Neuroendocrinos at 9 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase II trial to assess the activity and safety of PD0332991 in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Neuroendocrine Cancer
What is being tested?
Palbociclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
9 sitesSpain
Study dates
May 2015to Jan 2018
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

  • Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with Ki67 assessment of < or = 20% (well and moderately differentiated) with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
  • Overexpression of Cdk4 and/or phospho-Rb1 and/or cyclin D1 in tumor tissue sample from tumor biopsy or prior primary tumor resection (Molecular study will be conducted at CNIO and logistic is described later). Therefore availability of paraffin-embedding tumor tissue sample is needed.
  • Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.
  • Previous treatments with chemotherapy, antiangiogenics, or interferon are permitted providing that toxicity has resolved to < grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment. Patients may be treated with somatostatin analogues during the trial. Concomitant interferon treatment is not permitted.
  • Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
  • Able to swallow oral compound
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  • Male or female, 18 years of age or older.
  • ECOG performance status less than 2.
  • Life expectancy greater than 12 weeks.
  • The definitions of minimum adequacy for organ function required prior to study entry are as follows. In addition, safety precautions provided in the product labeling for the anticipated control arm chemotherapy must be observed.
  • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) 2.5 x upper limit of normal (ULN), or AST and ALT 5 x ULN if liver function abnormalities are due to underlying malignancy
  • Total serum bilirubin 1.5 x ULN
  • Serum albumin 3.0 g/dL
  • Absolute neutrophil count (ANC) 1500/L
  • Platelets 100,000/L
  • Hemoglobin 9.0 g/dL
  • Creatinin clearance < 40 mL/min
  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Prior chemotherapy regimen or biological treatment for locally advanced or metastatic transitional cell carcinoma of the urinary tract.
  • Prior treatment on Cdk4 inhibitor under clinical trial.
  • Creatinine clearance < 40 ml/min using Cockroft and Gault formula.
  • Major surgery, radiation therapy, or systemic therapy within 3 weeks of study randomization except palliative radiotherapy to non-target metastatic lesions.
  • Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
  • Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken concurrently or within last 3 months prior to randomization
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  • Prior radiation therapy to >25% of the bone marrow.
  • Current treatment on another clinical trial.
  • Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months prior to first dose of treatment on study and should be asymptomatic.
  • Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
  • Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, atrial XML File Identifier: 3xAP+CVEwV9UnEoC7xvloFQA/XQ=Page 20/34 fibrillation of any grade, or QTc interval >450 msec for males or >470msec for females.
  • Hypertension that cannot be controlled by medications (>150/100mmHg despite optimal medical therapy)
  • Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • Known human immunodeficiency virus infection.
  • Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • H. Vall d´Hebron

    Barcelona

  • H. Castellon

    Castelló, 12002

  • ICO

    L'Hospitalet de Llobregat, Barcelona

  • H U Ramón y Cajal

    Madrid

  • H. 12 Octubre

    Madrid

  • H.U.La Paz

    Madrid

  • H.U.C de Asturias

    Oviedo, Principality of Asturias

  • C. H. de Navarra

    Pamplona, Navarre

  • H.U.Virgen del Rocio

    Seville

Other trials in Spain

About this study

Official title: A Phase II Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)

A phase II trial to assess the activity and safety of PD0332991 in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)

Read the detailed description

The purpose of this study is to evaluate the activity and safety of PD0332991 in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) with overexpression of cell cycle markers (Cdk4 and/or phospho-Rb1 and/or cyclin D1)

Being tested
Palbociclib
Medical subject headings
Somatostatinoma

What participants receive

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

  • PalbociclibDrug

    Also called palbociclib (PD0332991)

    Palbociclib

Study groups in NCT02806648
Study groupRoleWhat they receive
PalbociclibExperimentalPalbociclib
Receives: Drug: Palbociclib

What is being measured

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

  1. Activity of palbociclib (PD0332991) considering objective response rate

    Measured: 20 months

Secondary outcomes (6)

  1. Progression Free Survival

    Measured: Patients will be followed until disease progression, estimating around 12months

  2. Time to Tumor Progression

    Measured: Patients will be followed until disease progression, estimating around 12 months

  3. Duration of response

    Measured: Patients will be followed until disease progression, estimating around 12 months

  4. Overall Survival

    Measured: Patients will be followed until death, estimating around 33 months

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Safety)

    Safety would be measured as Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: Patients will be followed until disease progression estimating around 12 months

  6. Positive expression of tumor biomarkers (Cdk4, Cdk6, fosfo-Rb1, D1 cyclin, p53, Ki67)

    Percentage of neoplasique cells with positive expression of the following tumor biomarkers Cdk4, Cdk6, fosfo-Rb1, D1 cyclin, p53, Ki67 would be measured at baseline by immunohistochemistry

    Measured: Positive expression of tumor biomarkers at baseline

Timeline

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

  1. First posted20 Jun 2016 (estimated)
  2. Study startMay 2015
  3. Primary completionJul 2017
  4. Study completionJan 2018

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02806648
Sponsor's protocol ID
GETNE-1407
Acronym
PALBONET
Status last verified
Jun 2016
First submitted
8 Jul 2015
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib in people with Pancreatic Neuroendocrine Cancer, run by Grupo Espanol de Tumores Neuroendocrinos at 9 sites in Spain.

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 19 inclusion and 17 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: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Activity of palbociclib (PD0332991) considering objective response rate (time frame: 20 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 NCT02806648.

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 23 Jan 2018.

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