NCT03275818: ABRADES

Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma

Completed Phase 2 Last updated 7 June 2022

What this trial tests

Phase 2 trial testing nab paclitaxel in Tumor, Desmoplastic Small Round Cell, Adult in 69 participants. Completed in 30 September 2021.

Timeline

9 May 2017

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	Grupo Espanol de Investigacion en Sarcomas
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	69
Start date	9 May 2017
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	7 locations across Spain

Drugs / interventions tested

• nab paclitaxel

Conditions studied

• Tumor, Desmoplastic Small Round Cell, Adult — all drugs for Tumor, Desmoplastic Small Round Cell, Adult →
• Tumor, Desmoplastic Small Round Cell, Childhood — all drugs for Tumor, Desmoplastic Small Round Cell, Childhood →
• Sarcoma, Ewing — all drugs for Sarcoma, Ewing →
• Sarcoma — all drugs for Sarcoma →

Sponsor

Grupo Espanol de Investigacion en Sarcomas — full company profile →

Who can join

Adults 6 Months to 80, any sex, with Tumor, Desmoplastic Small Round Cell, Adult or Tumor, Desmoplastic Small Round Cell, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in Spain.

Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round cell tumor or Ewing sarcoma (DSRCT and ES)

Nab-paclitaxel (ABRAXANE) will be administered as follows:

Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤ 20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days

Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason.

The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with improvement of pain with at least minimally important difference (MID) of 2 in subjects with desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT and ES cohort)

Publications & conference data

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

1. Desmoplastic Small Round Cell Tumor: A Review of Main Molecular Abnormalities and Emerging Therapy.
   Mello CA, Campos FAB, Santos TG, Silva MLG, et al · · 2021 · cited 50× · PMID 33525546 · DOI 10.3390/cancers13030498
2. Mini-Review on Targeted Treatment of Desmoplastic Small Round Cell Tumor.
   Bexelius TS, Wasti A, Chisholm JC. · · 2020 · cited 26× · PMID 32373525 · DOI 10.3389/fonc.2020.00518
3. Intra-Abdominal Desmoplastic Small Round Cell Tumor: Current Treatment Options and Perspectives.
   Wei G, Shu X, Zhou Y, Liu X, et al · · 2021 · cited 13× · PMID 34604040 · DOI 10.3389/fonc.2021.705760
4. Albumin-bound paclitaxel and gemcitabine combination therapy in soft tissue sarcoma.
   Tian Z, Zhang F, Li P, Wang J, et al · · 2020 · cited 12× · PMID 32723378 · DOI 10.1186/s12885-020-07199-0
5. Immunotherapy and Radioimmunotherapy for Desmoplastic Small Round Cell Tumor.
   Espinosa-Cotton M, Cheung NV. · · 2021 · cited 9× · PMID 34869013 · DOI 10.3389/fonc.2021.772862
6. The Controversial Role of Autophagy in Ewing Sarcoma Pathogenesis-Current Treatment Options.
   Koustas E, Sarantis P, Karamouzis MV, Vielh P, et al · · 2021 · cited 9× · PMID 33652741 · DOI 10.3390/biom11030355
7. Ewing Sarcoma Meets Epigenetics, Immunology and Nanomedicine: Moving Forward into Novel Therapeutic Strategies.
   Sánchez-Molina S, Figuerola-Bou E, Sánchez-Margalet V, de la Cruz-Merino L, et al · · 2022 · cited 7× · PMID 36358891 · DOI 10.3390/cancers14215473
8. A phase II trial of weekly nab-paclitaxel for progressive and symptomatic desmoid tumors.
   Martin-Broto J, Redondo A, Moura DS, Valverde C, et al · · 2022 · cited 3× · PMID 36271011 · DOI 10.1038/s41467-022-33975-6