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

Description

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

Conditions

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35249

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Scottsdale

HonorHealth Research Institute, Scottsdale, Arizona, United States, 85258

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Winston-Salem

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Minneamrita Therapeutics LLC,

Jordan Jacobs, MBA, STUDY_DIRECTOR, Translational Drug Development

Study Record Dates

2024-12-01