AzTrials
AzTrials

Metastatic Pancreatic AdenocarcinomaPhase 1/2SEQUENCENCT02504333

Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma

A Phase 1/2 study testing nab-paclitaxel, gemcitabine and m-FOLFOX in people with Metastatic Pancreatic Adenocarcinoma, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Adenocarcinoma
What is being tested?
nab-paclitaxel, gemcitabine and m-FOLFOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteSpain
Study dates
Jul 2015to Apr 2021
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

  • Histologically and/or cytologically confirmed pancreatic adenocarcinoma
  • Stage IV disease (metastatic only)
  • No prior systemic therapy for their diagnosis (except in adjuvant/neoadjuvant setting>six months previously)
  • ECOG performance status of 0-1
  • At least 18 years of age
  • Evidence of either or both of the following RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)
Show all 19Show fewer
  • Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.
  • Adequate bone marrow function:
  • ANC ≥ 1500/uL
  • platelet count ≥ 100,000/uL
  • hemoglobin ≥ 9.0 g/dL
  • Adequate hepatic function:
  • Total bilirubin ≤ 1.5 X ULN
  • AST (SGOT) ≤ 2.5 X ULN
  • ALT (SGPT) ≤ 2.5 X ULN
  • Adequate renal function as determined by either:
  • Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
  • Ability to understand the nature of this study protocol and give written informed consent.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
  • Presence of central nervous system or brain metastases.
  • Life expectancy < 12 weeks
  • Pregnancy (positive pregnancy test) or lactation.
  • Pre-existing sensory neuropathy > grade 1.
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
  • Major surgery and/or radiotherapy within 4 weeks of the start of study treatment, without complete recovery.
  • Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative for Digestive Tumour Therapy (TTD)

    Madrid, 28046

Other trials in Spain

About this study

Official title: A Phase I/II Study of Nab-paclitaxel (Abraxane) and Gemcitabine Followed by Modified FOLFOX (AG-mFOLFOX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma

Being tested
nab-paclitaxel, gemcitabine, m-FOLFOX
Keywords
metastatic pancreatic adenocarcinoma, Nab-paclitaxel, Gemcitabine, modified FOLFOX

What participants receive

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

  • nab-paclitaxelDrug

    Day 1-8-15: Intravenous, 125 mg/m2 over 30 minutes

  • gemcitabineDrug

    Day 1-8-15: Intravenous, 1.000 mg/m2 over 30 minutes

  • m-FOLFOXDrug

    Day 28 according to the dose levels stablished in Phase I

  • nab-paclitaxelDrug

    Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I

  • gemcitabineDrug

    Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I

Study groups in NCT02504333
Study groupRoleWhat they receive
AGActive comparatornab-Paclitaxel followed by Gemcitabine
Receives: Drug: nab-paclitaxel; Drug: gemcitabine
AG-mFOLFOXExperimentalnab-Paclitaxel followed by Gemcitabine and FOLFOXm at dose levels selected from the phase I trial
Receives: Drug: m-FOLFOX; Drug: nab-paclitaxel; Drug: gemcitabine

What is being measured

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

  1. Dose-limiting toxicity for the AG-mFOLFOX combination

    Primary outcome phase I.

    Measured: 12 weeks

  2. Rate of overall survival al 12 months

    Primary outcome phase II

    Measured: 12 weeks

Secondary outcomes (9)

  1. Rate of overall survival at 6 months

    Measured: 54 months

  2. Rate of overall survival at 24 months

    Measured: 54 months

  3. Time to tumor progression

    Measured: 54 months

  4. Progression free survival

    Measured: 54 months

  5. Overall Survival

    Measured: 54 months

  6. Objective radiographic response

    Secondary outcome Phase I and Phase II

    Measured: 54 months

  7. CA 19-9 biomarker response

    Measured: 54 months

  8. Safety profile of this combination (AG-mFOLFOX) using NCI-CTCAE v.4 criteria

    Secondary outcome Phase I and Phase II

    Measured: 54 months

  9. To assess the Quality of Life of the patients through the EORTC QLQ-C30/PAN26 and EORTC QLQ-CIPN20 questionnaires

    Secondary outcome Phase I and Phase II

    Measured: 54 months

Timeline

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

  1. First posted21 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionApr 2021
  4. Study completionApr 2021

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
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02504333
Sponsor's protocol ID
TTD-14-05
Acronym
SEQUENCE
Status last verified
Sep 2023
First submitted
20 Jul 2015
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
No

Publications

  • Carrato A, Pazo-Cid R, Macarulla T, Gallego J, Jimenez-Fonseca P, Rivera F, Cano MT, Rodriguez-Garrote M, Pericay C, Ales I, Layos L, Grana B, Iranzo V, Gallego I, Garcia-Carbonero R, de Mena IR, Guillen-Ponce C, Aranda E. Nab-Paclitaxel plus Gemcitabine and FOLFOX in Metastatic Pancreatic Cancer. NEJM Evid. 2024 Feb;3(2):EVIDoa2300144. doi: 10.1056/EVIDoa2300144. Epub 2024 Jan 23.

    PubMed 38320486

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nab-paclitaxel, gemcitabine and m-FOLFOX in people with Metastatic Pancreatic Adenocarcinoma, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site 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 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 3 Oct 2023. 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 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?

Dose-limiting toxicity for the AG-mFOLFOX combination (time frame: 12 weeks). 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 NCT02504333, 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 3 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in