Status:
COMPLETED
First-in-human Study of Oral TP-0184 in Patients With Advanced Solid Tumors
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
TP-0184 is a potent inhibitor of ALK2 or ACRV1 kinase, a constitutively active serine/threonine receptor kinase due to activating mutations or upregulated upstream signaling pathways. This is a Phase ...
Detailed Description
Primary Objective: • To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0184 administered once weekly for 4 weeks, over a range of doses in patients with adv...
Eligibility Criteria
Inclusion
- Have a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor
- Be refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.
- Have one or more tumors measurable or evaluable as outlined by modified RECIST v1.1
- Have an Eastern Cooperative Oncology Group (ECOG) (World Health Organization \[WHO\]) performance of ≤1
- Have a life expectancy ≥3 months
- Be ≥18 years of age
- Have a negative pregnancy test (if female of childbearing potential)
- Have acceptable liver function:
- Bilirubin ≤1.5x upper limit of normal (ULN)
- Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) and alkaline phosphatase ≤2.5x upper limit of normal (ULN) \*If liver metastases are present, then ≤5x ULN is allowed.
- Have acceptable renal function: Calculated creatinine clearance ≥ 30 mL/min
- Have acceptable hematologic status:
- Granulocyte ≥1500 cells/mm3
- Platelet count ≥100,000 (plt/mm3)
- Hemoglobin ≥8 g/dL (Patients may not have received prior transfusions within 2 weeks of the first dose of TP-0184)
- Have acceptable coagulation status:
- Prothrombin time (PT) within 1.5x normal limits
- Activated partial thromboplastin time (aPTT) within 1.5x normal limits
- Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation and for at least 3 months (males) and 6 months (females) after the last study drug dose. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Have read and signed the Institutional Review Board (IRB)-approved informed consent form (ICF) prior to any study related procedure. (In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new ICF must be signed.)
Exclusion
- History of congestive heart failure (CHF); cardiac disease, myocardial infarction within the past 6 months prior to Cycle 1 Day 1; left ventricular ejection fraction (LVEF) \<45% by echocardiogram (ECHO), unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) within 14 days prior to Cycle 1 Day 1
- Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>450 msec in men and \>470 msec in women
- Have a seizure disorder requiring anticonvulsant therapy
- Presence of symptomatic central nervous system metastatic disease or disease that requires local therapy such as radiotherapy, surgery, or increasing dose of steroids within the prior 2 weeks
- Have severe chronic obstructive pulmonary disease with hypoxemia (defined as resting O2 saturation of ≤90% breathing room air)
- Have undergone major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1
- Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Are pregnant or nursing
- Received treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days or 5 half lives, whichever occurs first, prior to study entry (6 weeks for nitrosoureas or Mitomycin C)
- Are unwilling or unable to comply with procedures required in this protocol
- Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Patients with history of chronic hepatitis that is currently not active are eligible.
- Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Are currently receiving any other investigational agent
- Have exhibited allergic reactions to a similar structural compound, biological agent, or formulation
- Have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption
- Have hemochromatosis or a transferrin saturation (TS) \>50% in men or \>45% in women at baseline or noted during the study via scheduled iron panel monitoring
Key Trial Info
Start Date :
July 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03429218
Start Date
July 10 2018
End Date
March 8 2021
Last Update
November 14 2023
Active Locations (5)
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1
Honor Health
Scottsdale, Arizona, United States, 85258
2
Northside Hospital
Atlanta, Georgia, United States, 30342
3
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160
4
Massachusetts General Hospital MGH
Boston, Massachusetts, United States, 02215