Clinical Trials /

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

NCT03129139

Description:

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

Related Conditions:
  • Breast Carcinoma
  • Gastric Carcinoma
  • Malignant Solid Tumor
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: Minnelide 101
  • NCT ID: NCT03129139

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

Interventions

DrugSynonymsArms
Minnelide™CapsulesRegimen A (monotherapy)

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

Trial Arms

NameTypeDescriptionInterventions
Regimen A (monotherapy)ExperimentalMinnelide™ 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.
  • Minnelide™Capsules
Regimen B (combination)ExperimentalMinnelideTM 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.
  • Minnelide™Capsules
Regimen C (monotherapy in Gastric Cancer)ExperimentalMinnelide™ 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.
  • Minnelide™Capsules

Eligibility 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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants With Treatment-Related Adverse Events
Time Frame:24 months
Safety Issue:
Description:as assessed by CTCAE V4 .03

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Minneamrita Therapeutics LLC

Trial Keywords

  • Metastatic

Last Updated

December 10, 2019