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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 (Minnelide 101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03129139
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
Translational Drug Development
Information provided by (Responsible Party):
Minneamrita Therapeutics LLC

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

Condition or disease Intervention/treatment Phase
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 Drug: Minnelide™Capsules Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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

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

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




Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events [ Time Frame: 24 months ]
    as assessed by CTCAE V4 .03

  2. Anti-tumor activity [ Time Frame: 24 months ]
    RECIST 1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129139


Contacts
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Contact: Cameron Wright, MS 6023588341 cwright@td2inc.com
Contact: Mohana Velagapudi, MD 3092693132 mvelagapudi@minneamrita.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact    205-934-9999      
Principal Investigator: Ravi K Paluri, MD         
United States, Arizona
Mayo Clinic Arizona Withdrawn
Phoenix, Arizona, United States, 85054
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN,RN,AOCNS    480-323-1364    Joyce.schaffer@honorhealth.com   
Principal Investigator: Erkut Borazanci, MD, MS         
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jaime Richardson, RN    310-423-2133    cancer.trial.info@cshs.org   
Principal Investigator: Monica Mita, MD         
United States, Florida
Mayo Clinic Terminated
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Terminated
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Minneamrita Therapeutics LLC
Translational Drug Development
Investigators
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Study Director: Cameron Wright, MS Translational Drug Development
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Responsible Party: Minneamrita Therapeutics LLC
ClinicalTrials.gov Identifier: NCT03129139    
Other Study ID Numbers: Minnelide 101
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Minneamrita Therapeutics LLC:
Metastatic
Additional relevant MeSH terms:
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Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases