Minnelide™ Capsules Alone and in Combination With Paclitaxel in Advanced Gastric Cancer

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ Capsules given alone or in combination with paclitaxel in patients with Advanced Gastric Cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Minneamrita Therapeutics LLC
• Treatments: 14-O-phosphonooxymethyltriptolide disodium salt

Criteria

Inclusion Criteria:

• Patients with histologically confirmed advanced gastric cancer

• Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy

• One or more metastatic tumors measurable per RECIST v1.1 Criteria

• Karnofsky performance ≥ 70%

• Life expectancy of at least 3 months

• Age ³ 19 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 ³ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

• Acceptable hematologic status:

• Granulocyte

• Monotherapy: ³ 1,500 cells/mm3

• Combination therapy with paclitaxel: ³ 2,000cells/mm3 Platelet count ³ 100,000 (plt/mm3)

• Hemoglobin ³ 9 g/dL

• Urinalysis:

o No clinically significant abnormalities

• Acceptable coagulation status:

• PT ≤ 1.5 times institutional ULN

• PTT ≤ 1.5 times institutional ULN

• Women of child- bearing potential and men must agree to use adequate contraception For men and women of child-producing potential, the use of effective contraceptive methods during the study and until 90 days after the last dose of IP for men or until 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women.

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: For men and women of child-producing potential, the use of effective contraceptive methods during the study and until 90 days after the last dose of IP for men or until 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women. 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 (local therapy, non-target lesion, 2 weeks), major surgery, chemotherapy, biological agents or investigational therapy within 3 weeks prior to study treatment.

• 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 4.3.2).

• Patients with biliary obstruction and/or biliary stent (Regimen B only)

• Patients with a history of severe hypersensitivity reactions to products containing Cremophor® EL (eg, cyclosporin for injection concentrate and teniposide for injection concentrate). • Patient with baseline ANC<1500/mm3