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Pancreatic AdenocarcinomaPhase 1MOAnab1NCT02174887

Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer

A Phase 1 study testing Nab-paclitaxel + Gemcitabine in people with Pancreatic Adenocarcinoma, run by Institut Paoli-Calmettes at 1 site in France.

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

The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold standard since the end of the 90s' is gemcitabine; unfortunately all trials testing combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to demonstrate any superiority over gemcitabine monotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Nab-paclitaxel + Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteFrance
Study dates
Sep 2014to Oct 2016
Phase
Phase 1
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

  • Age > 18 years
  • Suspicion of pancreatic adenocarcinoma
  • With liver measurable metastases
  • Primary tumor non resected
  • First line systemic treatment
  • Correct haematological parameters
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  • Adequate Blood chemistry levels
  • Life expectancy ≥ 2 months
  • PS: 0 - 2
  • Affiliation to French National social security or beneficiary
  • Signed informed consent.
  • Female patients must be surgically sterile, or be postmenopausal, or must commit to using reliable and appropriate methods of contraception during the study and during at least three months after the end of study treatment. All female patients with reproductive potential must have a negative pregnancy test (β HCG) within 72 hours prior to starting abraxane treatment. Breastfeeding is not allowed. Male patients must agree to use effective contraception in addition to having their partner use a contraceptive method as well during the trial and during at least six months after the end of the study treatment,

Who cannot join

  • Previous radiotherapy of the tumor
  • Patient has only locally advanced disease.
  • Previous treatment with gemcitabine
  • Active infection or severe concomitant disease
  • Serious Peripheral neuropathy
  • Known hypersensitivity or contraindication to any component of study drug formulation.
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  • Pregnant or breastfeeding women
  • Other experimental treatment
  • History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
  • Known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
  • Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity
  • Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary, Hypersensitivity pneumonitis or multiple allergies
  • Patient uses Coumadin
  • Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to complete the study or sign the consent.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Paoli-Calmettes

    Marseille, 13009

Other trials in France

About this study

Official title: A Unicentric, Open Label, Mechanism of Action Trial, on the Biological Effect of Nab-paclitaxel Combined to Gemcitabine, in Patients With Metastatic Pancreatic Adenocarcinoma

The prognostic of metastatic pancreatic adenocarcinoma is dismal and the treatment gold standard since the end of the 90s' is gemcitabine; unfortunately all trials testing combinations of gemcitabine with chemotherapeutic agents or targeted agents had failed to demonstrate any superiority over gemcitabine monotherapy.

In a recently published phase I/II study of combination of gemcitabine plus nab-paclitaxel in patients with metastatic pancreatic adenocarcinoma (PAC), the combination gave an impressive response rate of 48% (Gemcitabine 1g/m² and nab-paclitaxel 125 mg/m² once a week for 3 weeks, every 4 weeks). The safety profile was correct (fatigue, sensory neuropathy, nausea, haematological side effects). This efficacy can be related to an improvement of gemcitabine delivery to the tumor bed, as shown on preclinical studies: the response rate in xenografts was better with the combination; this improvement was associated with an increase of intratumoral gemcitabine concentration in mice receiving the combination when compared to mice receiving gemcitabine alone. This might be associated to modifications of peritumoral stroma with reduction of stromal content and increase in dilated vessels.

The aim of this study is to evaluate if the combination of nab-paclitaxel plus gemcitabine induces a modification in vascularization of pancreatic adenocarcinoma on the primary tumor and of liver metastases after 2 cycles of treatment by comparison to baseline.

Being tested
Nab-paclitaxel + Gemcitabine
Keywords
pancreatic adenocarcinoma, liver metastases

What participants receive

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

  • Nab-paclitaxel + GemcitabineDrug

    Gemcitabine 1 g/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days in combination with Nab-paclitaxel 125 mg/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days

    The patients will receive 2 cycles of treatment every 28 days:

Study groups in NCT02174887
Study groupRoleWhat they receive
Nab-paclitaxel + GemcitabineExperimentalGemcitabine 1 g/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days in combination with Nab-paclitaxel 125 mg/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days The patients will receive 2 cycles of treatment every 28 days
Receives: Drug: Nab-paclitaxel + Gemcitabine

What is being measured

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

  1. Vascularization parameters of pancreatic carcinoma

    Vascularization parameters of pancreatic carcinoma:

    • on the primary tumor assessed by contrast-enhanced harmonic endoscopic ultrasonography (EUS)
    • and on liver metastases assessed by contrast enhanced ultrasonography (ceUS)

    Measured: 2 months

Secondary outcomes (4)

  1. Stiffness

    Stiffness will be assessed in the primary tumor using ratio-elastography

    Measured: 2 months

  2. Density

    Density will be assessed in liver metastases on CTscan using density measurement before injection of contrast agent and after injection during the portal phase (80 sec post IV)

    Measured: 2 months

  3. Safety

    Adverse events of the treatment will be evaluated according to the Common Toxicity Criteria for Adverse Events (CTCAE version 4.03)

    Measured: 2 months

  4. Response rate

    Response rate will be evaluated according to RECIST V1.1 and CHOI criteria

    Measured: 2 months

Timeline

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

  1. First posted26 Jun 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionOct 2016
  4. Study completionOct 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02174887
Sponsor's protocol ID
MOAnab1-IPC 2012-010
Acronym
MOAnab1
Status last verified
Mar 2017
First submitted
24 Jun 2014
Last updated
28 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nab-paclitaxel + Gemcitabine in people with Pancreatic Adenocarcinoma, run by Institut Paoli-Calmettes at 1 site in France.

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 12 inclusion and 14 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 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.

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?

Vascularization parameters of pancreatic carcinoma (time frame: 2 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 NCT02174887.

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 28 Mar 2017.

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