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Triptolide Analog

Minnelide + Osimertinib for Lung Cancer

Phase 1
Recruiting
Led By Erminia Massarelli
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M
If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of minnelide given with osimertinib to treat non-small cell lung cancer that has spread and has a mutation in the EGFR gene.

Who is the study for?
Adults with advanced non-small cell lung cancer that has spread and have specific EGFR gene mutations. They must have had tumor progression after standard osimertinib treatment, be able to swallow pills, not be pregnant or breastfeeding, use effective birth control, and agree to research biopsies. Excluded are those with certain heart conditions, active infections requiring systemic therapy, recent use of strong CYP3A4 inducers/inhibitors or antiarrhythmic agents.Check my eligibility
What is being tested?
The trial is testing the combination of Minnelide (which turns into triptolide in the body) and Osimertinib for treating advanced lung cancer with EGFR mutations. It aims to find the best dose of Minnelide while checking how well it works alongside Osimertinib by blocking a protein needed for cancer cell growth.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills during drug administration, fatigue, digestive issues including nausea or diarrhea, blood disorders like anemia or clotting problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor has a specific EGFR mutation sensitive to certain treatments.
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My blood clotting time is within the target range for my anticoagulant therapy.
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I am a woman who can have children and have a recent negative pregnancy test.
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My blood clotting time is within the normal range and I'm not on blood thinners.
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My cancer has worsened despite taking osimertinib.
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I am 18 years old or older.
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My lung cancer cannot be treated with surgery or radiation aimed at a cure.
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My liver function test is within the required range.
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My blood clotting time is within the normal range and I'm not on blood thinners.
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I am able to care for myself but may not be able to do active work.
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My blood clotting time is within the target range for my anticoagulant therapy.
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I have taken osimertinib at 80 mg daily without severe side effects.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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I have recovered from cancer treatment side effects, except for hair loss and mild nerve pain.
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I can swallow and keep down pills.
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I am a man who will not father a child or donate sperm during and for 6 months after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) of osimertinib and minnelide
Recommended phase II dose (RP2D) of minnelide and osimertinib
Secondary outcome measures
Duration of overall response
Evidence of anti-tumor activity of minnelide when in combination with osimertinib
Incidence of adverse events
+4 more
Other outcome measures
Cell free deoxyribonucleic acid (DNA) in blood
Determination of the exosomes
Evaluation of the microbiome
+2 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
10%
Fatigue
10%
Blood creatine phosphokinase increased
8%
Diarrhoea
8%
Decreased appetite
8%
Cough
7%
Thrombocytopenia
7%
Constipation
7%
Mucosal inflammation
7%
Paronychia
7%
Pain in extremity
7%
Rash
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (minnelide, osimertinib)Experimental Treatment3 Interventions
Patients receive minnelide PO QD on days 1-21 and osimertinib PO QD on days 1-28. Cycles repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Biopsy
2014
Completed Phase 4
~840

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,222 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,365 Total Patients Enrolled
Erminia MassarelliPrincipal InvestigatorCity of Hope Medical Center

Media Library

Minnelide (Triptolide Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05166616 — Phase 1
Lung Carcinoma Research Study Groups: Treatment (minnelide, osimertinib)
Lung Carcinoma Clinical Trial 2023: Minnelide Highlights & Side Effects. Trial Name: NCT05166616 — Phase 1
Minnelide (Triptolide Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166616 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this research trial at present?

"Yes, data hosted on clinicaltrials.gov affirms that this clinical research is actively welcoming participants. The trial was first made available for review on March 7th 2022 and has been recently refreshed as of August 2nd 2022. 30 individuals will be accepted at the single recruitment site."

Answered by AI

Is this an innovative research endeavor?

"Currently, there are 101 active studies for Osimertinib that span 51 countries and 1059 cities. This medication was initially trialled in 2013, with AstraZeneca overseeing a Phase 1 & 2 trial involving 603 patients. Since then, 72 further investigations have been launched into this drug's potential efficacy."

Answered by AI

What research has been conducted to explore the efficacy of Osimertinib?

"Presently, there are 101 studies for Osimertinib with 17 in the latter stage of testing. These trials can be found predominantly in Uniondale, NY as well as across 4702 other sites internationally."

Answered by AI

To what extent can Osimertinib cause harm to individuals?

"The limited clinical data available surrounding osimertinib's safety and efficacy gives it a score of 1 on our scale."

Answered by AI

How many participants are joining this research project?

"Affirmative. According to clinicaltrials.gov, this research trial is actively recruiting participants and has been since March 7th 2022. A total of 30 test subjects need to be sourced from a single medical facility before the last update on August 2nd 2022."

Answered by AI
~7 spots leftby Dec 2024