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

Who is this study for? Patients with advanced solid tumors
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Mayo Clinic Arizona
WITHDRAWN
Phoenix
HonorHealth Research Institute
RECRUITING
Scottsdale
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Florida
Mayo Clinic
TERMINATED
Jacksonville
Minnesota
Mayo Clinic
TERMINATED
Rochester
North Carolina
Wake Forest Baptist Health
RECRUITING
Winston-salem
Contact Information
Primary
Jordan Jacobs, MBA
jjacobs@td2inc.com
602-358-8376
Backup
Mohana Velagapudi, MD
mvelagapudi@minneamrita.com
3092693132
Time Frame
Start Date: 2017-10-10
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 66
Treatments
Experimental: Regimen A (monotherapy)
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.
Experimental: Regimen B (combination)
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.
Experimental: Regimen C (monotherapy in Gastric Cancer)
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.
Sponsors
Collaborators: Translational Drug Development
Leads: Minneamrita Therapeutics LLC

This content was sourced from clinicaltrials.gov