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

Study Overview

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 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

N/A

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

Minnelide 101

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	Results Reporting Dates	Study Record Updates
First Submitted 2017-04-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-10-17
First Submitted that Met QC Criteria 2017-04-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-10-18
First Posted (ACTUAL) 2017-04-26	Results First Posted N/A	Last Verified 2023-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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 g	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.

Participant Group/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 g

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	Measure Description	Time Frame
Number of Participants With Treatment-Related Adverse Events	as assessed by CTCAE V4 .03	24 months
Anti-tumor activity	RECIST 1.1	24 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jordan Jacobs, MBA

Phone Number: 602-358-8376

Email: jjacobs@td2inc.com

Study Contact Backup

Name: Mohana Velagapudi, MD

Phone Number: 3092693132

Email: mvelagapudi@minneamrita.com

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

Acceptable hematologic status:

Granulocyte ≥ 1500 cells/mm3
Platelet count ≥ 100,000 (plt/mm3)
Hemoglobin ≥ 9 g/dL
Urinalysis:

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Translational Drug Development

Investigators

STUDY_DIRECTOR: Jordan Jacobs, MBA, Translational Drug Development

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record