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 | Unknown Phase 1 FDA Drug

• 1 other identifier: Minnelide 101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 7

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

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

Keywords

Metastatic

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Related Adverse Events

  as assessed by CTCAE V4 .03

  24 months

• Anti-tumor activity

  RECIST 1.1

  24 months

Study Arms (3)

Regimen A (monotherapy)

EXPERIMENTAL

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

Regimen B (combination)

EXPERIMENTAL

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

Regimen C (monotherapy in Gastric Cancer)

EXPERIMENTAL

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

Interventions

Minnelide™Capsules DRUG

Minnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor.

Regimen A (monotherapy); Regimen B (combination); Regimen C (monotherapy in Gastric Cancer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Minneamrita Therapeutics LLC: lead
• Translational Drug Development: collaborator

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

WITHDRAWN

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

TERMINATED

Mayo Clinic

Rochester, Minnesota, 55905, United States

TERMINATED

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Colonic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jordan Jacobs, MBA

  Translational Drug Development

  STUDY DIRECTOR

Central Study Contacts

Jordan Jacobs, MBA

CONTACT

602-358-8376; jjacobs@td2inc.com

Mohana Velagapudi, MD

CONTACT

3092693132; mvelagapudi@minneamrita.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 26, 2017
• Study Start: October 10, 2017
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)