Clinical Trials Logo

Clinical Trial Summary

Phase I, open-label, non-randomized study to evaluate safety of BC2059 administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive.


Clinical Trial Description

This study is a phase I, open-label, non-randomized study to evaluate safety of BC2059 administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive. This study will utilize single patient cohorts for the first two dose levels in order to minimize sub-optimal drug exposures, followed by a conventional 3+3 dose escalation phase to achieve MTD or RP2D determined by pharmacokinetics or biologically relevant activity. Once MTD or RP2D is determined, that dose level cohort will expand to 14 patients enrolled to collect additional safety PK and PD data. If at least 1 patient has clinical benefit, the dose expansion phase will be expanded by a further 11 patients (25 total in at RP2D). The total duration of study for each subject will be dependent upon the safety, tolerability and efficacy of BC2059 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03459469
Study type Interventional
Source Iterion Therapeutics
Contact
Status Completed
Phase Phase 1
Start date July 15, 2018
Completion date May 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05561036 - A Randomized, Double-blind,Phase Ⅲ Study of Liposome Doxorubicin in Desmoid Tumor Phase 3
Completed NCT00287846 - Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis Phase 1/Phase 2
Recruiting NCT06258421 - Burden of Disease and Living Situation in Desmoid Patients
Completed NCT00030680 - Radiation Therapy in Treating Patients With Aggressive Fibromatoses Phase 2
Recruiting NCT06081400 - Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting N/A
Active, not recruiting NCT04871282 - A Study of AL102 in Patients With Progressing Desmoid Tumors Phase 2/Phase 3
Recruiting NCT01567046 - Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas N/A
Completed NCT01137916 - Study to Evaluate Imatinib in Desmoid Tumors Phase 2
Completed NCT00002595 - Toremifene in Treating Patients With Desmoid Tumors Phase 2
Completed NCT06195085 - CT-guided Radioactive Iodine-125 Seed Implantation for Recurrent Desmoid Tumors
Completed NCT01286662 - A Cohort Study of Patients Treated With Brachytherapy for Selected Desmoid Patients in Gardner Syndrome N/A
Completed NCT01265030 - A Pilot Study Evaluating the Use of mTor Inhibitor Sirolimus in Children and Young Adults With Desmoid-Type Fibromatosis Phase 1/Phase 2
Completed NCT00068419 - Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor Phase 2
Completed NCT04289077 - Quality of Life of Patients With Desmoid-type Fibromatosis
Completed NCT03190174 - Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers Phase 1/Phase 2
Completed NCT00003019 - Vinblastine and Methotrexate in Treating Children With Desmoid Tumors Phase 2
Recruiting NCT05949099 - Study of Cryoablation and Nirogacestat for Desmoid Tumor Phase 2
Active, not recruiting NCT02076906 - MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors Phase 1
Completed NCT00474994 - Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas Phase 2
Active, not recruiting NCT03785964 - Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) Phase 3