A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors

Launched by MINNEAMRITA THERAPEUTICS LLC · Apr 21, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Minnelide™ capsules, which may help patients with advanced solid tumors, including types of cancer like breast, pancreatic, and gastric cancer. The trial is looking to see how safe the drug is and how it works in the body. Participants will take the capsules daily for 21 days, followed by a 7-day break. The study will also explore if combining Minnelide™ with another drug called protein-bound paclitaxel can be beneficial.

To be eligible for this trial, patients should be 18 years or older and have advanced solid tumors that have not responded to standard treatments. They should have measurable tumors and a good level of overall health, as indicated by a performance status score. It’s important for potential participants to discuss their health history with their doctor to see if they meet the criteria. If eligible, participants can expect regular check-ups to monitor their health and how the treatment is affecting them. Additionally, all participants will need to provide informed consent, meaning they understand the study and agree to take part.

Gender

ALL

Eligibility criteria

• Inclusion:
• • Patients with histologically confirmed advanced solid tumors (regimen A), breast or pancreas (regimen B), or gastric cancer (regimen C)
• • 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:
• • o Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• * Acceptable hematologic status:
• • Granulocyte ≥ 1500 cells/mm3
• • Platelet count ≥ 100,000 (plt/mm3)
• • Hemoglobin ≥ 9 g/dL
• * Urinalysis:
• • o 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 antiarrhythmic 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 (section 4.4.2).
• • Patients with biliary obstruction and/or biliary stent (Regimen B only)