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Microtubule Inhibitor

Utidelone Capsules for Advanced Cancer

Phase 1

Recruiting

Led By Jacob Thomas, MD

Research Sponsored by Biostar Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial tests the safety and efficacy of a drug called Utidelone for advanced solid tumors. It will measure effectiveness, safety, and the recommended dosage.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors that can't be cured and have no effective standard treatments left. They must be relatively healthy (ECOG score 0-1), expect to live at least 12 weeks, and have normal liver function tests, blood cell counts within certain limits, and agree to informed consent.Check my eligibility

What is being tested?

The trial is testing Utidelone Capsule's safety in patients with advanced solid tumors. It aims to find the highest dose patients can take without severe side effects (MTD) and identify any major toxic reactions (DLT). The study will also look into how the body processes the drug, its potential anti-tumor effects, and suggest dosing for future trials.See study design

What are the potential side effects?

While specific side effects of Utidelone Capsule are not listed here, common ones may include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. Liver function could also be affected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-Limiting Toxicity, DLT

Maximum Tolerated Dose, MTD

Secondary outcome measures

Maximum (or peak) serum concentration-Cmax

Objective Response Rate-ORR

Recommended Phase II Dose (RP2D)

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Utidelone Capsule at 75 mg/m2/d for 5 daysExperimental Treatment1 Intervention

Cohort 3: 3-6 subjects are planned to take Utidelone Capsule at 75 mg/m2/d by QD for 5 consecutive days in a 21-day cycle.

Group II: Utidelone Capsule at 50 mg/m2/d for 5 daysExperimental Treatment1 Intervention

Cohort 2: 2 subjects are planned to take Utidelone Capsule at 50 mg/m2/d by QD for 5 consecutive days in a 21-day cycle.

Group III: Utidelone Capsule at 25 mg/m2/d for 5 daysExperimental Treatment1 Intervention

Cohort 1: 2 subjects are planned to take Utidelone Capsule at 25 mg/m2/d by QD for 5 consecutive days in a 21-day cycle.

Group IV: Utidelone Capsule at 120 mg/m2/d for 7 daysExperimental Treatment1 Intervention

Cohort 6: 3-6 subjects are planned to take Utidelone Capsule at 120 mg/m2/d by QD for 7 consecutive days in a 21-day cycle.

Group V: Utidelone Capsule at 100 mg/m2/d for 7 daysExperimental Treatment1 Intervention

Cohort 5: 3-6 subjects are planned to take Utidelone Capsule at 100 mg/m2/d by QD for 7 consecutive days in a 21-day cycle.

Group VI: Utidelone Capsule at 100 mg/m2/d for 5 daysExperimental Treatment1 Intervention

Cohort 4: 3-6 subjects are planned to take Utidelone Capsule at 100 mg/m2/d by QD for 5 consecutive days in a 21-day cycle.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Biostar Pharma, Inc.Lead Sponsor

Jacob Thomas, MDPrincipal InvestigatorUniversity of Southern California

1 Previous Clinical Trials

10 Total Patients Enrolled

Frequently Asked Questions

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

Is recruitment for this research program ongoing?

"Confirming the information posted on clinicaltrials.gov, this experiment is actively recruiting participants since its first posting on June 9th 2023 and last update on November 7th 2023."

Answered by AI

How many participants are involved in this medical experiment?

"Affirmative. According to the documentation hosted on clinicaltrials.gov, this experiment was initially posted in June 9th 2023 and updated recently on November 7th 2023; 28 patients are currently being recruited from a single centre."

Answered by AI

To what end is this experiment intended to bring about?

"Biostar Pharma, Inc. have reported that the key metric they will be measuring during this 12-month trial is known as Dose Limiting Toxicity (DLT). Secondary metrics of study include Area Under Concentration Time Curve from dosing to time t (AUC0-t), Maximum Serum Concentration (Cmax) and Half Life clearance rate for Utidelone Capsule(t1/2)."

Answered by AI

Has the Federal Drug Administration given approval for patients to consume Utidelone Capsule at 100 mg/m2/d for 5 days?

"Combing through the evidence, our analysts at Power have concluded that Utidelone Capsule at 100 mg/m2/d for 5 days is relatively safe and has been given a score of 1 considering this medication is in its initial phase of clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors

2023. "Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05681000.