A Phase Ib Trial of Neoadjuvant AMG-232 Concurrent with Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)
Principal Investigator
Meng Welliver, MD PhD
Status
Terminated
Date Opened To Accrual
November 03 2017
Date Closed to Accrual
September 07 2022
Date of Study Termination
September 04 2025
Disease Site
Other [DT]
Sarcoma
Phase
I
Developmental Therapeutics
Yes
Primary Objective
To evaluate the safety and tolerability of AMG 232 in combination with standard-dose radiotherapy in STS in two separate patient cohorts (A, extremity or body wall; B, abdomen/pelvis/retroperitoneum)
To determine the maximum tolerated dose/recommended phase II dose (MTD/RP2D) of AMG 232 in combination with radiotherapy
Patient Population
Patients with pathologically proven diagnosis of grade 2-3 (intermediate or high grade) soft tissue sarcoma with size ≥5 cm with the intention to treat curatively. Patients must have sufficient tissue to submit to central laboratory for review as well as for NGS sequencing.
Target Accrual
46
Protocol Documents
- NRG-DT001 Study Memorandum Activation November 3, 2017.pdf
- NRG-DT001 Study Memorandum Amendment 3_June 4 2018_final.pdf
- NRG-DT001 Study Memorandum Amendments 1 and 2_January 3, 2018.pdf
- NRG-DT001 Study Memorandum Amendment 5_July 1, 2019.pdf
- NRG-DT001 Study Memorandum Amendment 4 and Reopened_November 21, 2018.pdf
- NRG-DT001 Study Memorandum_Cohort A Reopening DL2_June 4, 2019.pdf
- NRG-DT001 Study Memorandum_Temporary Closure December 6, 2019.pdf
- NRG-DT001 Study Memorandum_Temporary Closure March 12, 2019.pdf
- NRG-DT001 Study Memorandum_Cohort A Reopening DL3_February 10, 2020.pdf
- NRG-DT001 Study Memorandum_Temporary Closure February 21, 2020.pdf
- NRG-DT001 Study Memorandum Amendment 6_March 3, 2020-2.pdf
- UPDATED-Action-Letter-KRT-232 (AMG-232)-NCS789723-v2.2-2-28-2020.pdf
- NRG-DT001 Study Memorandum_COVID19_Analytical Core Lab Closure_March 17, 2020.pdf
- NRG-DT001 Study Memorandum_Cohort B Reopening DL2_April 28, 2020.pdf
- NRG-DT001 Study Memorandum_COVID19_Analytical Core Lab Reopening_June 15, 2020.pdf
- NRG-DT001 Study Memorandum_Temporary Closure July 21, 2020.pdf
- NRG-DT001 Study Memorandum_Cohort A_Expansion Cohort_Reopening DL3_September 15, 2020.pdf
- NRG-DT001 Study Memorandum_Analytical Core Lab Update_10.19.20.pdf
- NRG-DT001 Study Memorandum_Analytical Core Lab Holiday Shipping_12.10.20.pdf
- NRG-DT001 Study Memorandum Amendment 7 RRA_March 11, 2021.pdf
- Action-Letter- KRT-232 (AMG 232)-NSC 789723-v2.3-03-9-2021.pdf
- NRG-DT001 Study Memorandum_Temporary Closure September 10, 2021.pdf
- NRG-DT001 Study Memorandum_Cohort A Permanent Closure_November 18, 2021.pdf
- NRG-DT001 Study Memorandum Amendment 8_December 20, 2021.pdf
- NRG-DT001 Study Memorandum_Cohort B Closure Notice_August 31, 2022.pdf
- NRG-DT001 Study Memorandum_Cohort B Closure_September 7, 2022.pdf
- NRG Oncology Study Terminations September 4, 2025.pdf
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.