NCT02587169: GEIS-27

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

Status unknown Phase 1/Phase 2 Last updated 23 October 2015

What this trial tests

Phase 1/Phase 2 trial testing Nilotinib-adriamycin in Retroperitoneal Liposarcoma in 40 participants. Status unknown.

Timeline

1 January 2012

Primary endpoint
1 December 2015

1 December 2015

Quick facts

Lead sponsor	Broto, Javier Martín, M.D.
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 January 2012
Primary completion	1 December 2015
Estimated completion	1 December 2015
Sites	20 locations across Spain

Drugs / interventions tested

• Nilotinib-adriamycin — full drug profile →

Conditions studied

• Retroperitoneal Liposarcoma — all drugs for Retroperitoneal Liposarcoma →
• Retroperitoneal Leiomyosarcoma — all drugs for Retroperitoneal Leiomyosarcoma →
• Chondrosarcoma — all drugs for Chondrosarcoma →

Sponsor

Broto, Javier Martín, M.D. — full company profile →

Who can join

Adults 18 to 70, any sex, with Retroperitoneal Liposarcoma or Retroperitoneal Leiomyosarcoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Relapse-free survival (RFS) at 5 years
  Time frame: 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.

Sponsor's own description

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.

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Targets and Emerging Treatments in Advanced Chondrosarcoma.
   Miwa S, Yamamoto N, Hayashi K, Takeuchi A, et al · · 2022 · cited 34× · PMID 35163019 · DOI 10.3390/ijms23031096
2. Selection of Effective Therapies Using Three-Dimensional <i>in vitro</i> Modeling of Chondrosarcoma.
   Palubeckaitė I, Venneker S, Briaire-de Bruijn IH, van den Akker BE, et al · · 2020 · cited 14× · PMID 33425984 · DOI 10.3389/fmolb.2020.566291
3. Targeting liposarcoma: unveiling molecular pathways and therapeutic opportunities.
   Liu H, Wang X, Liu L, Yan B, et al · · 2024 · cited 2× · PMID 39723387 · DOI 10.3389/fonc.2024.1484027