Advanced Cancer, Breast Cancer, Cancer of Stomach, Colo-rectal Cancer, Gastric Cancer, Pancreatic Cancer, Prostate Cancer Metastatic, Solid Carcinoma, Solid Carcinoma of Stomach, Solid Tumor
Conditions
Keywords
Metastatic
Brief 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
Interventions
DRUGMinnelide™Capsules
Minnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor.
Sponsors
Translational Drug Development
Minneamrita Therapeutics LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | 24 months | as assessed by CTCAE V4 .03 |
| Anti-tumor activity | 24 months | RECIST 1.1 |
Countries
United States
Contacts
Primary ContactJordan Jacobs, MBA
Backup ContactMohana Velagapudi, MD
Outcome results
None listed