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

Phase 1

Recruiting

• Conditions: Advanced Cancer; Breast Cancer; Pancreatic Cancer; Prostate Cancer Metastatic; Solid Carcinoma of Stomach; Cancer of Stomach; Colo-rectal Cancer; Solid Tumor; Gastric Cancer; Solid Carcinoma
• Interventions: Drug: Minnelide™Capsules

• Registration Number: NCT03129139
• Lead Sponsor: Minneamrita Therapeutics LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Study Start: 2017-10-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen A (monotherapy)	Minnelide™Capsules	Minnelide™ Capsules will be given as a single agent orally once daily x 21 days followed by a 7-day off schedule. One cycle will equal 28 days. MinnelideTM Capsules should be given with the patient in a fasting state.
Regimen B (combination)	Minnelide™Capsules	MinnelideTM Capsules will be given orally once daily x 21 days in combination with protein-bound paclitaxel given intravenously on days 1, 8 and 15 in patients with pancreas and breast cancer. One cycle will equal 28 days. MinnelideTM Capsules should be given with the patient in a fasting state.
Regimen C (monotherapy in Gastric Cancer)	Minnelide™Capsules	Minnelide™ Capsules will be given as a single agent orally once daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days. Minnelide™ Capsules should be given with the patient in a fasting state.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events	24 months	as assessed by CTCAE V4 .03
Anti-tumor activity	24 months	RECIST 1.1

Trial Locations

Locations (6)

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States