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Clinical Trial 19604

Cancer Type: Gastrointestinal Tumor

Study Type: Treatment
Phase of Study: Phase II

  • Dae Won Kim

Call 813-745-6100
or 1-800-679-0775

Study Title

A Phase II Multi-Center Study of SM-88 in Subjects with Pancreatic Cancer Whose Disease Has Progressed or Recurred after/on First Line Chemotherapy



Primary Efficacy Endpoints OS (overall survival) in this subject population. Overall response rate (complete response + partial response) by central review of modified RECIST 1.1 using blinded independent central review (BICR) of radiological scans. Secondary Endpoints PFS (Progression-free survival) in this patient population by central review of modified RECIST 1.1 using BICR of radiological scans. Overall response rate (complete response + partial response) by central review of using BICR of radiological scans based on PERCIST 1.0 criteria. Disease control rate (confirmed and unconfirmed; complete response + partial response + stable disease) by central review of modified RECIST 1.1 BICR of radiological scan. Duration of response (DoR) 4Tin this subject population by central review of modified RECIST 1.1 BICR of radiological scans. Population pharmacokinetics (PK) of D,L-alpha-metyrosine and all the components of SM-88 in subjects with pancreatic cancer using sparse sampling. Measurement of circulating tumor cells (CTC) The effect of SM-88 on patient-reported outcomes including quality of life (as measured by the EORTC QLQ-30 and EORTC QLQPAN26)in subjects with pancreatic cancer. Safety Endpoints Safety laboratory measurements. Adverse Events. Physical exam findings (e.g. ophthalmologic assessments). Vital signs, ECGs. Subject tolerability/acceptability. Discontinuations/terminations.

Inclusion Criteria

  • Biopsy-proven metastatic pancreatic adenocarcinoma with documented radiographic disease progression on or after one or more systemic therapies. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy. Chemotherapy given for at least 4 months as adjuvant after complete response is considered as a first line therapy.
  • Participants must be unwilling or unable to tolerate other non-study systemic chemotherapy.
  • Participants must have measurable lesions (according to standard RECIST 1.1).
  • Participants must have completed systemic therapy at least 28 days prior to first dose.
  • Participants must have recovered from major side effects of prior therapies or procedures.
  • 18 years of age or older.
  • ECOG performance status ≤2.
  • Life expectancy greater than 3 months, in the judgment of the investigator.
  • Adequate organ function.
  • Coagulation: International normalized ratio (INR) ≤1.2 within 28 days of starting study.
  • All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before baseline, with the exception of alopecia and neurotoxicity (CTCAE Grade 1 or 2 permitted).
  • Able and willing to provide written informed consent to participate in this study.
  • Participant willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Participants must be able to swallow whole capsule.
  • Female participants must either be of non-reproductive potential, not breast-feeding or must have a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1.
  • Participants of fertile potential who engage in heterosexual intercourse with 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

  • Exclusion Criteria

  • Any screening laboratory, electrocardiogram (ECG), or other findings that, in the opinion of the investigator or the sponsor, indicate an unacceptable risk for the subject'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 subject's safety or interfere with the study evaluations, procedures, or completion.
  • History of a concurrent or second malignancy, except for adequately treated local basal cell or squamous cell carcinoma of the skin, adequately treated 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.
  • Participants with MSI-H pancreatic cancer who have not previously received pembrolizumab.
  • Radiation to all target lesions within 12 weeks of study baseline,
  • No measurable target lesions.
  • Current use, or up to 14 days prior use, of certain prohibited medication or requires any of these medications during treatment phase.
  • Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision 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.
  • Any dysphagia, odynophagia, esophageal dysmotility or stricture, known GI malabsorption syndrome, or intractable diarrhea that may significantly alter the absorption of any of the components of SM-88, e.g., cirrhosis.
  • Known human immunodeficiency (HIV) virus infection
  • Known hepatitis B surface antigen (HBsAg) positive.
  • Known hepatitis C virus (HCV) antibody positive.
  • Have previously been enrolled in this study or any other study investigating SM-88 or who have previously received any component of SM-88 in a clinical trial.
  • History of any drug allergies or significant adverse reactions to any of the components of SM-88.
  • 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.
  • Participants must not have any clinically significant and uncontrolled major medical condition(s).
  • Greater than 10% weight loss over the 28 days prior to consent.
  • Participant has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
  • Participants with central nervous system metastasis; with the exception of participants who have stable brain metastases as defined as off steroids and no CNS progress for 6 months after CNS treatment.
  • Pregnant or lactating women.
  • History of psychiatric drug abuse that cannot be ended, or participants with mental disorders that will prevent compliance or evaluation including uncontrolled schizophrenia, uncontrolled depression or other uncontrolled disorders.
  • Participants with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins; or a history of prior acute hepatotoxicity attributable to phenytoin.
  • Participants exhibiting idiosyncratic reactions to psoralen compounds.
  • Participants with a hypersensitivity to sirolimus.
  • Participants with a history of the light sensitive diseases for which methoxsalen would be contraindicated.
  • Participants treated, or anticipated to be treated, with delavirdine .
  • Participants with melanoma or with a history of melanoma, invasive squamous cell carcinomas, or aphakia (due to contraindication for use of methoxsalen).
  • Participants with prior organ transplant or being treated, or anticipated to be treated, with cyclosporine.
  • Other exclusions apply