A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ Capsules in Patients With Advanced Solid Tumors

Overview

About this study

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Patients with histologically confirmed advanced solid tumors (regimen A) or breast or pancreas (regimen B).
  • Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy.
  • Prior treatment with protein-bound paclitaxel allowed if it has been six months since received or progressed on protein-bound paclitaxel and plan to continue to receive protein-bound paclitaxel with MinnelideTM capsules.
  • One or more metastatic tumors measurable per RECIST v1.1 Criteria.
  • Karnofsky performance ≥ 70%.
  • Life expectancy of at least 3 months.
  • Age: ≥ 18 years.
  • Signed, written IRB-approved informed consent.
  • A negative pregnancy test (if female).
  • Acceptable liver function:
    • Bilirubin ≤ 1.5 times upper limit of normal;
    • AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed);
    • Albumin ≥ 3.0 g/dL. 
  • Acceptable renal function:
    • Serum creatinine within normal limits, OR calculated creatinine clearance 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Acceptable hematologic status:
    • Granulocyte ≥ 1500 cells/mm^3;
    • Platelet count ≥ 100,000 (plt/mm^3);
    • Hemoglobin ≥ 9 g/dL.
  • Urinalysis:
    • No clinically significant abnormalities.
  • Acceptable coagulation status:
    • PT ≤ 1.5 times institutional ULN; 
    • PTT ≤ 1.5 times institutional ULN. 
  • For men and women of child-producing potential, the use of effective contraceptive methods during the study.

Exclusion Criteria:

  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
  • Baseline QTc exceeding 470 msec (using the Bazett's formula) and/or patients receiving class 1A or class III antiarrythmic agents.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  • Pregnant or nursing women.
    • NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
  • Unwillingness or inability to comply with procedures required in this protocol.
  • Known infection with HIV, hepatitis B, or hepatitis C.
  • Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
  • Patients who are currently receiving any other investigational agent.
  • Patients who are on a prohibited medication.
  • Patients with biliary obstruction and/or biliary stent (Regimen B only).

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ciara O'Sullivan, M.B., B.Ch.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Kabir Mody, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20411291

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