RECRUITING

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

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Conditions

Advanced CancerGastric CancerBreast CancerPancreatic CancerProstate Cancer MetastaticColo-rectal CancerSolid TumorSolid CarcinomaSolid Carcinoma of StomachCancer of StomachMetastatic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2017-10-10
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03129139

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * 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
  2. * Baseline QTc exceeding 470 msec (using the Bazett's formula) and/or patients receiving class 1A or class III antiarrhythmic agents.
  3. * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  4. * 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.
  5. * Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
  6. * Unwillingness or inability to comply with procedures required in this protocol
  7. * Known infection with HIV, hepatitis B, or hepatitis C
  8. * 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
  9. * Patients who are currently receiving any other investigational agent
  10. * Patients who are on a prohibited medication (section 4.4.2).
  11. * Patients with biliary obstruction and/or biliary stent (Regimen B only)

Contacts and Locations

Study Contact

Jordan Jacobs, MBA
CONTACT
602-358-8376
jjacobs@td2inc.com
Mohana Velagapudi, MD
CONTACT
3092693132
mvelagapudi@minneamrita.com

Principal Investigator

Jordan Jacobs, MBA
STUDY_DIRECTOR
Translational Drug Development

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
HonorHealth Research Institute
Scottsdale, Arizona, 85258
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Minneamrita Therapeutics LLC

  • Jordan Jacobs, MBA, STUDY_DIRECTOR, Translational Drug Development

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-10
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2017-10-10
Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

  • Metastatic

Additional Relevant MeSH Terms

  • 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