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

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