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
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
- 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
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
| Arm | Description | Assigned 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. |
|
|
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. |
|
|
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. |
|
Recruiting Locations
Birmingham, Alabama 35249
205-934-9999
More Details
- Status
- Recruiting
- Sponsor
- Minneamrita Therapeutics LLC