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



Status:Recruiting
Conditions:Breast Cancer, Prostate Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:October 10, 2017
End Date:December 1, 2020
Contact:Cameron Wright, MS
Email:cwright@td2inc.com
Phone:6023588341

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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


Inclusion Criteria:

- Patients with histologically confirmed advanced solid tumors (regimen A) or breast or
pancreas (regimen B)

- 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 MinnelideTMcapsules

- One or more metastatic tumors measurable per RECIST 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)

- 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 450 msec (using the Bazett's formula) and/or patients receiving
class 1A or class III antiarrythmic 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
We found this trial at
6
sites
Phoenix, Arizona 85054
Principal Investigator: Ramesh Ramanathan, MD
Phone: 855-776-0015
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Ravi K Paluri, MD
Phone: 205-934-9999
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Kabir Mody, MD
Phone: 855-776-0015
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Monica Mita, MD
Phone: 310-423-2133
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Rochester, Minnesota 55905
Principal Investigator: Ciara O'Sullivan, M.B., B.Ch
Phone: 855-776-0015
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Rochester, MN
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Scottsdale, Arizona 85258
Principal Investigator: Erkut Borazanci, MD, MS
Phone: 480-323-1339
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Scottsdale, AZ
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