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Advanced Pancreatic CancerPhase 1/2FRAGANCENCT02382263

Nab-paclitaxel in Combination With Gemcitabine in Fragile Patients With Advanced Pancreatic Cancer

A Phase 1/2 study testing Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4, Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4 and Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4 in people with Advanced Pancreatic Cancer, run by PH Research, S.L. at 15 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

In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the 6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000 deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the USA. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4, Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4 and Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
15 sitesSpain
Study dates
Apr 2013to Apr 2016
Phase
Phase 1/2
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

  • Patients who are 18 years or older;
  • Patients with histological or, if not possible, cytologic confirmed adenocarcinoma of the pancreas.
  • Patients with metastatic pancreatic cancer;
  • Patient with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2
  • Adequate hematopoietic, hepatic and renal function:
  • Neutrophil count >= 1.5 x 10*9/L;
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  • Platelet count >= 100 x 10*9/L;
  • Bilirubin <= 1.5 x ULN;
  • AST and/or ALT <= 2.5 x ULN;
  • Serum creatinine <= 1.5 x ULN.
  • Investigators must ensure that patients enrolled in the study will be available for all study procedures, including tumor biopsy, chemotherapy treatment, and follow up.
  • Investigators must ensure that patients have the ability to understand the requirements of the study and provide signed informed consent.
  • Women of childbearing potential and men who wish to participate in the study must agree to use adequate contraception since the signing of informed consent until at least 3 months after stopping the study medication;
  • Signed Informed Consent.

Who cannot join

  • Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with patient eligibility for treatment;
  • History of any psychiatric condition that might impair patient?s ability to understand or to comply with the requirements of the study or to provide informed consent;
  • Concurrent anticancer therapy;
  • Pregnant or breast-feeding women (documented methods of birth control are required in those with reproductive potential);
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs;
  • History of life threatening reaction to gemcitabine or abraxane;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <=1.
  • Previous treatment with chemotherapy or chemoradiotherapy for advanced pancreatic cancer.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, A Coruña, 15006

  • Hospital Universitari Vall D'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Complejo Hospitalario Regional Virgen de Las Nieves

    Granada, Granada, 18014

  • Complejo Hospitalario Gregorio Marañón

    Madrid, Madrid, 28007

  • Hospital Ramón Y Cajal

    Madrid, Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital Universitario Madrid Sanchinarro

    Madrid, Madrid, 28050

  • Complejo Hospitalario Regional de Málaga

    Málaga, Málaga, 29010

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Cosuña, 15706

  • Hospital Universitari I Politècnic La Fe

    Valencia, Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: Phase I/II Study to Assess the Efficacy and Safety of Nab-paclitaxel in Combination With Gemcitabine for the Treatment of Fragile Patients With Advanced or Metastatic Pancreatic Cancer

In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the 6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000 deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%, respectively. Most patients are diagnosed in advanced stages that are no longer operable, so that treatment goals are often the prolongation of survival and palliation of symptoms.

The aim of the study is to explore whether the new combination nab-paclitaxel plus gemcitabine is a therapeutic advance for this fragile population for which it is assumed that some modifications in dose and schedule of administration may be necessary in patients with good performance status. It is ultimately to find out the clinical benefit of this combination, but first making sure that dose and schedule of the combination are tolerable for these fragile patients.

For this, the investigators have chosen a design that includes two stages: the first step aimed at choosing the safest treatment regimen for these patients among a group of treatment regimens used in other clinical trials. The second step will evaluate the effectiveness of the two regimens with the better results in the previous step.

Being tested
Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4, Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4, Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4, Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4
Keywords
Advanced pancreatic cancer, Fragile, Nab-paclitaxel

What participants receive

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

  • Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4Drug

    Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle

  • Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4Drug

    Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

  • Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4Drug

    Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle

  • Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4Drug

    Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

Study groups in NCT02382263
Study groupRoleWhat they receive
Arm BExperimentalNab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4
Receives: Drug: Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4
Arm CExperimentalNab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4
Receives: Drug: Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4
Arm DExperimentalNab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4
Receives: Drug: Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4
Arm EExperimentalNab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4
Receives: Drug: Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

What is being measured

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

  1. PHASE I: To select the schemes with the best therapeutic indexes of the combination of gemcitabine and nab-paclitaxel in fragile patients with advanced pancreatic cancer.

    Phase I: Therapeutic index. Criteria: Early mortality all causes at 30 and 60 days, Adverse Events grade 3 and 4, treatment discontinuation due to toxicity and relative dose intensity

    Measured: Up to 2 months

  2. PHASE II: Evaluate the effectiveness of two selected schemes of gemcitabine and nab-paclitaxel, vs. gemcitabine alone. (Six months overall survival)

    Six months overall survival

    Measured: Up to 6 months

Secondary outcomes (6)

  1. Phase I: evaluate safety profile of gemcitabine and nab-paclitaxel schemes. (Number of events per patient according to NCI-CTC-AE criteria)

    Number of events per patient according to NCI-CTC-AE criteria

    Measured: Up to 6 months

  2. Phase I: evaluate objective response rate. (Response rate will be evaluated according RECIST criteria)

    Response rate will be evaluated according RECIST criteria

    Measured: Up to 6 months

  3. Phase II: progression free survival (Time from randomization to disease progression according RECIST criteria)

    Time from randomization to disease progression according RECIST criteria

    Measured: Up to 8 months

  4. Phase II: objective response rate (Response rate will be evaluated according RECIST criteria)

    Response rate will be evaluated according RECIST criteria

    Measured: Up to 6 months

  5. Phase II: to explore changes induced by treatment on tumor Marker CA19.9

    Measured: Up to 8 months

  6. Phase II: change in FAP and Cav-1 tumor markers as an inidicatior of treatment efficacy

    Measured: Up to 6 months

Timeline

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

  1. First posted6 Mar 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02382263
Sponsor's protocol ID
PHR-2012-01
Acronym
FRAGANCE
Status last verified
Jul 2016
First submitted
24 Feb 2015
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4, Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4 and Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4 in people with Advanced Pancreatic Cancer, run by PH Research, S.L. at 15 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 14 inclusion and 8 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

PHASE I: To select the schemes with the best therapeutic indexes of the combination of gemcitabine and nab-paclitaxel in fragile patients with advanced pancreatic cancer. (time frame: Up to 2 months). The study lists 2 primary outcomes in all. 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 NCT02382263.

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 6 Jul 2016.

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