Recruiting
Phase 1

Minnelide™ & Protein-Bound Paclitaxel

Sponsor:

Minneamrita Therapeutics LLC

Code:

NCT03129139

Conditions

Advanced Cancer

Gastric Cancer

Breast Cancer

Pancreatic Cancer

Prostate Cancer Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Minnelide™Capsules

Study Details

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

Conditions

Advanced Cancer

Gastric Cancer

Breast Cancer

Pancreatic Cancer

Prostate Cancer Metastatic

Study ID

NCT03129139

Start date

Oct 10, 2017

Status verified date

Oct, 2023

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Jun 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

66 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Minnelide™Capsules

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

Primary outcome measure

  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: 24 months ]
  • Anti-tumor activity [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Jordan Jacobs, MBA

602-358-8376jjacobs@td2inc.com

Mohana Velagapudi, MD

3092693132mvelagapudi@minneamrita.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

205-934-9999

Principal Investigator:

Ravi K Paluri, MD

HonorHealth Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Joyce Schaffer, MSN,RN,AOCNS

480-323-1364Joyce.schaffer@honorhealth.com

Principal Investigator:

Erkut Borazanci, MD, MS

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Jaime Richardson, RN

310-423-2133cancer.trial.info@cshs.org

Principal Investigator:

Monica Mita, MD

Wake Forest Baptist Health

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Austin Humbert

336-713-6912ahumbert@wakehealth.edu

Principal Investigator:

Ravi K Paluri, MD

More Information

Sponsor

Minneamrita Therapeutics LLC

Last update posted

Oct 18, 2023

Last verified

Oct, 2023

Keywords

  • Metastatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Minneamrita Therapeutics LLC on 2023-10-18.