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Retroperitoneal LiposarcomaPhase 1/2GEIS-27NCT02587169

Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum

A Phase 1/2 study testing Nilotinib-adriamycin in people with Retroperitoneal Liposarcoma and Retroperitoneal Leiomyosarcoma, run by Broto, Javier Martín, M.D. at 20 sites in Spain.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Phase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant treatment in liposarcomas and leiomyosarcomas of retroperitoneum. The main objective of this study is to improve relapse-free survival (RFS)and overall survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Nilotinib-adriamycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
20 sitesSpain
Study dates
Jan 2012to Dec 2015
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histological diagnosis of well differentiated liposarcoma, dedifferentiated liposarcoma or primary leiomyosarcoma of retroperitoneum and resectable. In phase I the study will recruit patients with high-grade chondrosarcoma of non-mesenchymal type.
  • Age: 18-70 years.
  • Measurable disease, according to RECIST criteria.
  • Functional status: 0-1 (ECOG).
  • Baseline medullar function (hemoglobin > 10 g/dL, leukocytes ≥ 3.000/mm3, RAN≥ 1,5 x 109 /l, granulocytes ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Patients with alteration of transaminases ≤ 2.5 times the normal limits, bilirubin total ≤ LSN, CPK≤ 2.5 times the normal limits, alkaline phosphatase ≤ 2.5 times more the normal limits or creatinine values ≤ 1.6 mg/dL, are accepted.
  • Cardiac function (LVEF) normal, considering the normal ranges of the institution.
  • The patient must voluntarily sign the informed consent before any trial test, knowing that he/she can leave the trial at any time, without any consequence for his/her posterior medical attention.
  • Patients in fertile age (both male and female) must use an effective contraceptive method before the entry in the study and during the trial. Moreover, women must maintain contraceptive measures up to 5 months after the treatment. Pregnancy must be ruled out though urine test (negative pregnancy test) for study enrolment.

Who cannot join

  • Patients having received previous chemotherapy.
  • Patient having been irradiated on the tumoral disease.
  • Functional status > 1 (ECOG).
  • Metastasis in any location.
  • Bilirubin values over the normal level. Creatinine over 1.6 mg/dL.
  • History of another oncological disease except basalioma or in situ cervical carcinoma adequately treated.
Show all 14Show fewer
  • Serious cardiovascular diseases (dyspnea >= 2 NYHA, ie.)
  • Systemic pathologies limiting survival to less than 2 years, limiting patient availability, or those that, by clinical judgement, may interfere significantly with treatment toxicity.
  • Bacterial, viral, or uncontrolled mycotic infectious diseases.
  • Pregnant or lactating patients.
  • Psychological, family, sociological or geographical situations not allowing protocol fulfilment or informed consent signature.
  • Patients currently involved in other clinical trials receiving any other agent under investigation.
  • Patient having participated in a clinical trial and/or having received an agent under investigation in the 30 days prior to enrolment.
  • Patients requiring treatments with prolongation of QT interval as amiodarone, disopyramide, procainamide, quinidine, and sotalol.

Trial locations and contacts

20 sites in 1 country.

Patricio J. Ledesma, BEng contact

+34 648414261

pledesma@sofpromed.com

Santiago Blasco, BSc contact

+34 971439900

registros@sofpromed.com

20 sites in 1 country

Spain20 sites, 20 recruiting

  • Hospital Infanta Cristina

    Badajoz

    Ignacio Delgado, MD, ignadelgado@hotmail.com

    Ignacio Delgado, MD

    Recruiting

  • Hospital Universitari Germans Trials i Pujol

    Badalona

    Olatz Etxaniz, MD, oetxaniz@iconcologia.net

    Olatz Etxaniz, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

    Antonio López-Pousa, MD, alopezp@santpau.cat

    Antonio López-Pousa, MD

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona

    Claudia Valverde, MD, cmvalver@vhebron.net

    Claudia Valverde, MD

    Recruiting

  • Hospital Provincial de Castellón

    Castellon

    Ramón de las Peñas, MD, ramon.delaspenas@hospital2000.net

    Ramón de las Peñas, MD

    Recruiting

  • Complejo Asistencial Universitario de León

    León

    Luis Miguel de Sande, MD, lmgdesande@hotmail.com

    Luis Miguel de Sande, MD

    Recruiting

  • Hospital Puerta de Hierro

    Madrid

    Ricardo Cubedo, MD, rcubedo@gmail.com

    Ricardo Cubedo, MD

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Andrés Redondo, MD, aredondo12@gmail.com

    Andrés Redondo, MD

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid

    Mª Ángeles Vaz, MD, mavaz3@yahoo.es

    Mª Ángeles Vaz, MD

    Recruiting

  • Hospital Universitario Virgen de la Arrixaca

    Murcia

    Jerónimo Martínez, MD, jeronimo@seom.org

    Jerónimo Martínez, MD

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands

    Javier Martín, MD, PhD, +34 871205705, javier.martin@ssib.es

    Javier Martín, MD, PhD

    Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona

    Nuria Láinez, MD, nuria.lainez.milagro@cfnavarra.es

    Nuria Láinez, MD

    Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna

    Josefina Cruz, MD, jcruzjurado@gmail.com

    Josefina Cruz, MD

    Recruiting

  • Hospital Marqués de Valdecilla

    Santander

    Ana de Juan, MD, ajuan@humv.es

    Ana de Juan, MD

    Recruiting

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela

    Yolanda Vidal, MD, yvidalinsua@yahoo.es

    Yolanda Vidal, MD

    Recruiting

  • Hospital Virgen del Rocío

    Seville

    Pilar Sancho, MD, sanchomarquez@gmail.com

    Pilar Sancho, MD

    Recruiting

  • Hospital Virgen de la Salud

    Toledo

    Javier Medina, MD, boladiez39@yahoo.es

    Javier Medina, MD

    Recruiting

  • Instituto Valenciano de Oncología

    Valencia

    Javier Lavernia, MD, javilavernia@hotmail.com

    Javier Lavernia, MD

    Recruiting

  • Hospital Xeral Cies

    Vigo

    Juan Antonio Carrasco, MD, juan.antonio.carrasco.alvarez@sergas.es

    Juan Antonio Carrasco, MD

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza

    Javier Martínez-Trufero, MD, jmtrufero@seom.org

    Javier Martínez-Trufero, MD

    Recruiting

Other trials in Spain

About this study

Official title: GEIS-27: Phase I/II Multicenter and Prospective Trial of Nilotinib and Adriamycin as Neoadjuvant Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum

Phase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant treatment in liposarcomas and leiomyosarcomas of retroperitoneum.

The main objective of this study is to improve relapse-free survival (RFS)and overall survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in patients with resected sarcoma of retroperitoneum.

Read more

Secondary objectives include the analysis of antitumoral activity through response rate (RECIST and tissular changes), the assessment of positive correlation between biomarkers and clinical results, the study of long term overall survival, and the analysis of the safety profile of the nilotinib-adriamycin combination.

The trial hypothesis is that the nilotinib-adriamycin combination is synergistic and therefore better response results are expected (from 20% as P0 to 40% as P1). The study seeks to find a positive correlation between biomarkers and clinical results in retroperitoneal liposarcoma and leiomyosarcoma treated with the mentioned combination.

The study involves the participation of 20 hospitals of the Spanish Sarcoma Group (GEIS). The treatment consists of 4 neoadjuvant cycles of nilotinib-adriamycin on patients with resectable retroperitoneal sarcoma. The research comprises a robust translational study as well as histological and radiological reviews.

Read the detailed description

The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).

Phase I includes patients with retroperitoneal liposarcoma, retroperitoneal leiomyosarcoma and chondrosarcoma. Phase II is focused on retroperitoneal liposarcoma and leiomyosarcoma only.

Being tested
Nilotinib-adriamycin
Keywords
liposarcoma, leiomyosarcoma, retroperitoneum, chondrosarcoma
Medical subject headings
Retroperitoneal liposarcoma, Chondrosarcoma, Liposarcoma, Leiomyosarcoma

What participants receive

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

  • Nilotinib-adriamycinDrug

    Also called Nilotinib Tasigna, Doxorubicin hydrochloride

    The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).

Study groups in NCT02587169
Study groupRoleWhat they receive
Nilotinib-adriamycinExperimentalThe nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).
Receives: Drug: Nilotinib-adriamycin

What is being measured

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

  1. Relapse-free survival (RFS) at 5 years

    The main goal of the study is to improve relapse-free survival (RFS) and overall survival (OS) decreasing from 50% to 30% the percentage of relapse at 5 years in patients with resected retroperitoneal sarcoma.

    Measured: 5 years

Secondary outcomes (3)

  1. Objective response rate (ORR) (confirmed complete response [CR] and partial response [PR])

    To determine the objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) using RECIST 1.1 criteria

    Measured: Baseline and at 4 months

  2. Overall survival (OS)

    Overall survival measured from treatment start date until date of death, whichever the cause, assessed up to 100 months

    Measured: 100 months

  3. Number of adverse events

    Number and type of adverse events according to CTCAE 4.0

    Measured: 4 months

Timeline

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

  1. First posted27 Oct 2015 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02587169
Sponsor's protocol ID
EC10-150 RETRONEO
Other IDs
2011-002368-26, GEIS-27
Acronym
GEIS-27
Status last verified
Oct 2015
First submitted
17 Jul 2013
Last updated
27 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nilotinib-adriamycin in people with Retroperitoneal Liposarcoma and Retroperitoneal Leiomyosarcoma, run by Broto, Javier Martín, M.D. at 20 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 8 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: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

Results are not available in the source record.

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

Contact Patricio J. Ledesma, BEng (+34 648414261, pledesma@sofpromed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival (RFS) at 5 years (time frame: 5 years). 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 NCT02587169.

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 27 Oct 2015.

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