Status:
TERMINATED
Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy
Lead Sponsor:
Albert Einstein College of Medicine
Conditions:
Metastatic dMMR Solid Cancer
Solid Tumor
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of sirolimus by estimating the overall response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) in patients with metastatic dM...
Detailed Description
Despite recent therapeutic strategies, including immunotherapy, treatment alternatives for patients with metastatic mismatch-repair deficient (dMMR) solid tumors remain scarce. Pre-clinical data sugge...
Eligibility Criteria
Inclusion
- Metastatic solid cancer tumor after immunotherapy (either due to progression of disease or inability to tolerate treatment)
- dMMR by immunohistochemistry (IHC) defined as the loss of expression in any of the four major MMR proteins (MLH1, MSH2, MSH6 and PMS2) or by next- generation sequencing (NGS)
- Age older than 18 at the time of informed consent
- Eastern Cooperative Oncology Group performance status of 0-2
- ≥1 measurable lesion based on RECIST, version 1.1 (16)
- Absolute neutrophil count (ANC) ≥1,500 mm3
- Platelet count ≥75,000 mm3
- Hemoglobin ≥ 9 g/dl
- Aspartate aminotransferase (AST) ≤3.0 times the upper normal limit (UNL)
- Alanine aminotransferase (ALT) ≤3.0 times the upper normal limit (UNL) Bilirubin ≤1.5 times the UNL
- Serum creatinine ≤1.5 times the UNL
Exclusion
- Received immunotherapy in the prior 21 days.
- Have not recovered from toxicities of prior treatments to at least grade 1.
- Symptomatic central nervous system (CNS) metastases
- Pregnancy or Breast-feeding.
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04393454
Start Date
November 16 2020
End Date
May 16 2023
Last Update
July 25 2024
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10461