Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35249
Contact:
205-934-9999

More Details

Status
Recruiting
Sponsor
Minneamrita Therapeutics LLC

Study Contact

Cameron Wright, MS
6023588341
cwright@td2inc.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.