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

Breast Cancer Clinical Trial

— Minnelide 101  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129139
• Other study ID #: Minnelide 101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 10, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Minneamrita Therapeutics LLC
• Contact: Jordan Jacobs, MBA
• Phone: 602-358-8376
• Email: jjacobs[@]td2inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Cancer
• Breast Cancer
• Cancer of Stomach
• Carcinoma
• Colo-rectal Cancer
• Gastric Cancer
• Pancreatic Cancer
• Prostate Cancer Metastatic
• Solid Carcinoma
• Solid Carcinoma of Stomach
• Solid Tumor
• Stomach Neoplasms

Intervention

Drug:
• Minnelide™Capsules
Minnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Mayo Clinic	Jacksonville	Florida
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	HonorHealth Research Institute	Scottsdale	Arizona
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Minneamrita Therapeutics LLC	Translational Drug Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Related Adverse Events	as assessed by CTCAE V4 .03	24 months
Primary	Anti-tumor activity	RECIST 1.1	24 months