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)
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ClinicalTrials.gov Identifier: NCT03129139 |
Recruitment Status :
Recruiting
First Posted : April 26, 2017
Last Update Posted : April 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 |
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, 2022 |
Estimated Study Completion Date : | December 1, 2022 |

Arm | Intervention/treatment |
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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.
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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. |
- Number of Participants With Treatment-Related Adverse Events [ Time Frame: 24 months ]as assessed by CTCAE V4 .03
- Anti-tumor activity [ Time Frame: 24 months ]RECIST 1.1

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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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
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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.
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Acceptable hematologic status:
- Granulocyte ≥ 1500 cells/mm3
- Platelet count ≥ 100,000 (plt/mm3)
- Hemoglobin ≥ 9 g/dL
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Urinalysis:
o No clinically significant abnormalities
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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)

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
Contact: Jordan Jacobs, MBA | 602-358-8376 | jjacobs@td2inc.com | |
Contact: Mohana Velagapudi, MD | 3092693132 | mvelagapudi@minneamrita.com |
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 | |
United States, North Carolina | |
Wake Forest Baptist Health | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Austin Humbert 336-713-6912 ahumbert@wakehealth.edu | |
Principal Investigator: Ravi K Paluri, MD |
Study Director: | Jordan Jacobs, MBA | Translational Drug Development |
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 6, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Metastatic |
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 |