Advanced CancerPhase 1Minnelide 101NCT03129139
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 1 study testing Minnelide™Capsules in people with Advanced Cancer and Gastric Cancer, run by Minneamrita Therapeutics LLC at 7 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Gastric Cancer, Breast Cancer
- What is being tested?
- Minnelide™Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Oct 2017to 1 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 4 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35249
205-934-9999
Ravi K Paluri, MD
- Terminated
Mayo Clinic
Jacksonville, Florida, 32224
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Jaime Richardson, RN, 310-423-2133, cancer.trial.info@cshs.org
Monica Mita, MD
- Withdrawn
Mayo Clinic Arizona
Phoenix, Arizona, 85054
- Terminated
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Joyce Schaffer, MSN,RN,AOCNS, 480-323-1364, Joyce.schaffer@honorhealth.com
Erkut Borazanci, MD, MS
- Recruiting
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Austin Humbert, 336-713-6912, ahumbert@wakehealth.edu
Ravi K Paluri, MD
About this study
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, Colo-rectal Cancer
- Being tested
- Minnelide™Capsules
- Keywords
- Metastatic
- Medical subject headings
- Stomach Neoplasms, Breast Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minnelide™CapsulesDrug
Minnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Regimen A (monotherapy) | Experimental | 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. Receives: Drug: Minnelide™Capsules |
| Regimen B (combination) | Experimental | 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. Receives: Drug: Minnelide™Capsules |
| Regimen C (monotherapy in Gastric Cancer) | Experimental | 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. Receives: Drug: Minnelide™Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events
as assessed by CTCAE V4 .03
Measured: 24 months
Anti-tumor activity
RECIST 1.1
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start10 Oct 2017
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneamrita Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development
- Responsible party
- Sponsor
- Investigators
- Jordan Jacobs, MBA, Study director, Translational Drug Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129139
- Sponsor's protocol ID
- Minnelide 101
- Acronym
- Minnelide 101
- Status last verified
- Oct 2023
- First submitted
- 18 Apr 2017
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03129139
- Acronym / sponsor ID
- Minnelide 101 / Minnelide 101
- Conditions
- Advanced Cancer, Gastric Cancer, Breast Cancer, Pancreatic Cancer, Prostate Cancer Metastatic, Colo-rectal Cancer
- Keywords
- Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Minneamrita Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regimen A (monotherapy) | Experimental | Drug: Minnelide™CapsulesMinnelide™ 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. |
| Regimen B (combination) | Experimental | Drug: Minnelide™CapsulesMinnelideTM 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. |
| Regimen C (monotherapy in Gastric Cancer) | Experimental | Drug: Minnelide™CapsulesMinnelide™ 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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%
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minnelide™CapsulesMinnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor. | Drug | Regimen A (monotherapy), Regimen B (combination), Regimen C (monotherapy in Gastric Cancer) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Jacobs, MBA study director
Translational Drug Development
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minnelide™Capsules in people with Advanced Cancer and Gastric Cancer, run by Minneamrita Therapeutics LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan Jacobs, MBA (602-358-8376, jjacobs@td2inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.