Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer, Rising Prostate Specific Antigen (PSA)

In brief

The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88 in patients with prostate cancer

Key facts

Study ID

NCT02796898

Run by

Tyme, Inc

People needed

23

Starts

2016-06-01

Expected to finish

2019-05-30

Last updated by the study team

2019-07-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male ≥18 years of age.
• Histologically or cytologically confirmed prostate cancer (patients with neuroendocrine carcinoma of the prostate are excluded).
• Documented PSA progression. Pre-enrollment PSA progression will be as defined by the PCWG3 criteria, e.g. 3 values, increasing, each >7 days apart.
• ECOG performance status ≤1
• Life expectancy >3 months, in the judgment of the investigator.
• Adequate organ function defined as follows:
• Hematologic: Platelets ≥100 x 109 /L; Absolute Neutrophil Count (ANC) ≥1.5 x 109/L (without platelet transfusion or growth factors within the 7 days prior to the screening laboratory assessment)
• Hepatic: aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN); total or conjugated bilirubin ≤1.5 x ULN
• Renal: serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥60 mL/min as calculated by the Cockroft-Gault method
• Coagulation: International normalized ratio (INR) ≤1.2
• With or without one prior line of chemotherapy
• With or without prior or current ADT or hormone based therapy (up to 2 lines total)
• Cannot tolerate standard chemotherapy, hormone based therapy or ADT, or elects to opt out of standard therapies.
• Patients who are on ADT prior to the study need not discontinue such therapy during the study, but the use of ADT during the study must be documented.
• All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before baseline, with the exception of alopecia (Grade 1 or 2 permitted) and neurotoxicity (Grade 1 or 2 permitted)
• Male patients of fertile potential who engage in heterosexual intercourse with female partners of childbearing potential must agree to use highly effective contraception while enrolled in the study and for at least 6 months following the last dose of study drug. Highly effective birth control methods include the following (the patient should choose 2 to be used with their partner):
• Oral, injectable, or implanted hormonal contraceptives
• Condom with a spermicidal foam, gel, film, cream, or suppository
• Occlusive cap (diaphragm or cervical/vault cap) with a spermicidal foam, gel, film, cream, or suppository
• Intrauterine device
• Intrauterine system (for example, progestin-releasing coil)
• Vasectomized male (as determined by the investigator)
• Able and willing to provide written informed consent to participate in this study

You may not qualify if…

• PSA minimum starting value <1 ng/mL at trial entry.
• Metastatic disease as detected on bone scan, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or CT-positron emission tomography (PET) beyond the prostate or post-surgical prostate area.
• Any screening laboratory, electrocardiogram (ECG), or other findings that, in the opinion of the investigator or the sponsor, indicate an unacceptable risk for the patient's participation in the study.
• History or evidence of any clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor would pose a risk to the patient's safety or interfere with the study evaluations, procedures, or completion. Examples include intercurrent illness such as active uncontrolled infection, active or chronic bleeding event within 28 days of baseline, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
• History of a concurrent or second malignancy, except for adequately treated local basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission; or any other cancer that has been in complete remission for ≥5 years
• Local therapy such as radiation or surgery within 8 weeks of study baseline.
• Current use of a prohibited medication (see Section 8.5) or requires any of these medications during treatment phase
• Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than that required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first dose of study drug
• Minor surgical procedures within 7 days of baseline, or not yet recovered from prior surgery
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of any of the components of SM88, e.g. cirrhosis
• Known human immunodeficiency (HIV) virus infection
• Hepatitis B surface antigen (HBsAg) positive
• Hepatitis C virus (HCV) antibody positive
• Have previously been enrolled in this study or any other study investigating SM88
• History of any drug allergies or significant adverse reactions to any of the components of SM88.
• Are currently enrolled in, or have discontinued within 30 days of screening, from a clinical trial involving an investigational product or non-approved use of a drug or device.

Where it is running

• AdvanceMed Research — Lawrence, New Jersey, United States
• AccuMed Research Associates — Garden City, New York, United States
• Montefiore Medical Center- Montefiore Medical Park — The Bronx, New York, United States
• Eastchester Center for Cancer Care — The Bronx, New York, United States
• MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States

Full record on ClinicalTrials.gov

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