Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Phase II Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy

ID
Name
2019-10724
Description
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 dMMR solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment).
Trial arms
Trial start
2020-06-03
Estimated PCD
2023-05-16
Trial end
2023-05-16
Status
Terminated
Phase
Early phase I
Treatment
Sirolimus 2Mg Tab
Sirolimus (oral) will be started at 2 mg daily. Sirolimus dosing will be titrated to meet serum trough levels of \>8 ng/ml, assayed at 7 days after starting a new dose, by chromatography/nmass spectrometry. Once adequate serum levels are met (≥8 ng/ml), the same dosing will be continued until progression of disease as evidenced by imaging, or unacceptable toxicity.
Arms:
Sirolimus
Size
6
Primary endpoint
Overall Response Rate
6 months
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}
Updated at
2023-10-05

1 organization

1 product

4 indications

Organization
Albert Einstein College of Medicine
Product
Sirolimus
Indication
Metastatic dMMR Solid Cancer
Indication
Solid Tumor
Indication
Cancer
Indication
Metastatic Solid Tumor