Minnelide™ Capsules Alone and in Combination With Paclitaxel in Advanced Gastric Cancer

NCT05566834 | Unknown Phase 1 DMC

• 1 other identifier: Minnelide GC 101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ Capsules given alone or in combination with paclitaxel in patients with Advanced Gastric Cancer.

Conditions

Gastric Cancer

Keywords

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• To determine any increase of treatment emergent adverse events when Minnelide capsules are given in combination with paclitaxel.

  To observe any increase in the number of patients that experience Grade 4 neutropenia lasting ≥ 5 days or Grade 3 or 4 neutropenia with fever and/or infection; Grade 4 thrombocytopenia (or Grade 3 with bleeding); Grade 3 or 4 treatment-related non-hematological toxicity (Grade 3 nausea, vomiting or diarrhea that last \> 72 hours despite maximal treatment when Minnelide is given alone and in combination with paclitaxel compared to the incidence with gemcitabine and nab-paclitaxel.

  24 months

Secondary Outcomes (2)

• Pharmacokinetics of Minnelide when given with paclitaxel

  24 months

• Plasma levels of Minnelide when given with paclitaxel

  24 months

Study Arms (1)

Open-label, dose-escalation, safety, Pharmacodynamic, pharmacokinetic study.

EXPERIMENTAL

One

Drug: Minnelide

Interventions

Minnelide DRUG

at the MTD dose level established for monotherapy or combination to confirm safety. With a sample of 12 patients, the probability is \> 80% that a serious adverse event with at least a 16% incidence will be detected.

Open-label, dose-escalation, safety, Pharmacodynamic, pharmacokinetic study.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed advanced gastric cancer
• Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy
• One or more metastatic tumors measurable per RECIST v1.1 Criteria
• Karnofsky performance ≥ 70%
• Life expectancy of at least 3 months
• Age ³ 19 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 ³ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• Acceptable hematologic status:

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: For men and women of child-producing potential, the use of effective contraceptive methods during the study and until 90 days after the last dose of IP for men or until 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women. 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 (local therapy, non-target lesion, 2 weeks), major surgery, chemotherapy, biological agents or investigational therapy within 3 weeks prior to study treatment.
• 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 4.3.2).
• Patients with biliary obstruction and/or biliary stent (Regimen B only)
• Patients with a history of severe hypersensitivity reactions to products containing Cremophor® EL (eg, cyclosporin for injection concentrate and teniposide for injection concentrate). • Patient with baseline ANC\<1500/mm3

Sponsors & Collaborators

• Minneamrita Therapeutics LLC: lead

Study Sites (1)

Samsung Medical Center

Soeul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

14-O-phosphonooxymethyltriptolide disodium salt

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Mohana Velagapudi

  Minneamrita Therapeutics LLC

  STUDY DIRECTOR

Central Study Contacts

Mohana Velagapudi, MD

CONTACT

3092693132; mvelagapudi@minneamrita.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Minnelide™ is a water soluble disodium salt variant of triptolide, a diterpenoid, an HSP70 inhibitor. Studies using orthotopic pancreatic cancer cell lines and human xenograft transplants demonstrate that Minnelide™ prevents tumor progression, increases survival, and causes tumor regression.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 4, 2022
• Study Start: November 2, 2020
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)