A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
NCT ID: NCT01829971
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
155 participants
INTERVENTIONAL
2013-04-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MRX34
Single agent MRX34
MRX34
micro RNA therapy
Interventions
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MRX34
micro RNA therapy
Eligibility Criteria
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Inclusion Criteria
2. Patients with histologically confirmed viral related hepatocellular, SCLC, non-cutaneous/ non-uveal melanoma, ovarian, TNBC, Sarcoma, Bladder and RCC.
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
4. Acceptable liver function:
* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); for patients with hepatocellular carcinoma only, total bilirubin ≤ 3 mg/dL (i.e. Child-Pugh Score for bilirubin is no greater than 2).
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 5 x ULN.
5. Acceptable renal function:
• Serum creatinine ≤ 1.5 times the ULN, or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above 1.5 times the institutional normal
6. Acceptable hematological status:
* Absolute Neutrophil Count (ANC) ≥ 1500 cells/mm3
* Platelet count ≥ 100,000 plts/mm3 (without transfusion); ≥ 75,000 plts/mm3 for patients with hepatocellular carcinoma only. For hematologic malignancy patients blood counts cited above do not apply
* Hemoglobin ≥ 9 g/dL
* For the hematologic malignancy patients, blood count values cited above do not apply.
7. Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.25 x ULN; for patients with hepatocellular carcinoma only, INR \<1.7 or prothrombin time (PT) or \< 4 seconds above ULN (i.e. Child-Pugh Score is no greater than 1 for the coagulation parameter); for patients with hepatocellular carcinoma only, serum albumin \> 2.8 g/dL (i.e. Child-Pugh Score for albumin is no greater than 2). For the hematologic malignancy patients, the coagulation and albumin status cited above do not apply
8. For patients with hepatocellular carcinoma only, Child-Pugh Class A (score 5-6) disease. Score for hepatic encephalopathy must be 1; the score for ascites must be no greater than 2 and clinically irrelevant; for the determination of the Child-Pugh Class.
Exclusion Criteria
2. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
3. Pregnant or nursing women.
4. Known infection with human immunodeficiency virus (HIV).
5. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, heart failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
6. Patients with recent history of hemorrhage and patients predisposed to hemorrhage due to coagulopathies or structural anomalies.
7. Patients who require treatment with therapeutic doses of coumadin-type anticoagulants (maximum daily dose of 1mg allowed for port line patency permitted).
8. Patients with cirrhosis classed as Child-Pugh B or C.
9. Patients with central nervous system (CNS) metastasis. Intrathecal chemotherapy is allowed for patients who require CNS prophylaxis or therapy.
10. Patients for whom dexamethasone is contraindicated.
18 Years
ALL
No
Sponsors
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Cancer Prevention Research Institute of Texas
OTHER
Mirna Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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O'Neill VIncent, MD
Role: STUDY_DIRECTOR
Mirna Therapeutics
Locations
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Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Texas Oncology Dallas
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Uthscsa/Ctrc
San Antonio, Texas, United States
Severance Hospital, Yonsie University Health System
Seoul, Seodaemun-Gu, South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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References
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Lucibello G, Mograbi B, Milano G, Hofman P, Brest P. PD-L1 regulation revisited: impact on immunotherapeutic strategies. Trends Mol Med. 2021 Sep;27(9):868-881. doi: 10.1016/j.molmed.2021.06.005. Epub 2021 Jun 26.
Hong DS, Kang YK, Borad M, Sachdev J, Ejadi S, Lim HY, Brenner AJ, Park K, Lee JL, Kim TY, Shin S, Becerra CR, Falchook G, Stoudemire J, Martin D, Kelnar K, Peltier H, Bonato V, Bader AG, Smith S, Kim S, O'Neill V, Beg MS. Phase 1 study of MRX34, a liposomal miR-34a mimic, in patients with advanced solid tumours. Br J Cancer. 2020 May;122(11):1630-1637. doi: 10.1038/s41416-020-0802-1. Epub 2020 Apr 2.
Other Identifiers
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MRX34-101
Identifier Type: -
Identifier Source: org_study_id
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