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RNA-targeted therapy

Dose Level 2 for Chromosomal Instability

Phase 1

Recruiting

Research Sponsored by Volastra Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Able to take oral medication without alteration

ECOG Performance Status ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

"This trial will test the safety and effectiveness of a drug called sovilnesib in patients with a type of ovarian cancer. The goal is to determine the best dose of the drug for further testing in

Who is the study for?

This trial is for adults over 18 with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that's metastatic or can't be surgically removed. They should have tried platinum-based therapy but had the cancer return within 6 months or didn't respond to it at all. Participants may have had prior treatments like bevacizumab unless they're intolerant or ineligible.Check my eligibility

What is being tested?

The study tests different doses of Sovilnesib to find a safe and effective level for phase 2 trials in patients with advanced ovarian cancer. It's randomized, meaning participants are put into groups by chance to receive varying doses and their responses are compared.See study design

What are the potential side effects?

While specific side effects of Sovilnesib aren't listed here, common ones in such trials include nausea, fatigue, diarrhea, risk of infection due to low blood counts, liver issues, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills without needing to change them.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Determination of the Recommended Phase 2 Dose (RP2D) of Sovilnesib

Frequency and duration of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

Frequency and duration of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0

+3 more

Secondary outcome measures

Disease Control Rate (DCR) as assessed by RECIST version 1.1

Duration of Response (DOR) as assessed by RECIST version 1.1

Evaluation of CA-125 response by Gynecologic Cancer InterGroup (GCIG) criteria

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Level 4Experimental Treatment1 Intervention

Subjects will receive sovilnesib once daily at Dose Level 4 in 28-day cycles.

Group II: Dose Level 3Experimental Treatment1 Intervention

Subjects will receive sovilnesib once daily at Dose Level 3 in 28-day cycles.

Group III: Dose Level 2Experimental Treatment1 Intervention

Subjects will receive sovilnesib once daily at Dose Level 2 in 28-day cycles.

Group IV: Dose Level 1Experimental Treatment1 Intervention

Subjects will receive sovilnesib once daily at Dose Level 1 in 28-day cycles.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Volastra Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

186 Total Patients Enrolled

1 Trials studying Chromosomal Instability

120 Patients Enrolled for Chromosomal Instability

Frequently Asked Questions

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

Is the recruitment phase of this clinical trial still ongoing?

"The current status on clinicaltrials.gov indicates that patient recruitment is ongoing for this particular trial. This study was initially posted on April 4, 2024, and the most recent update was made on April 16, 2024."

Answered by AI

How many individuals in total are enrolled in this research project?

"Indeed, the details on clinicaltrials.gov show that this specific clinical trial is currently seeking suitable candidates. The initial posting date was 4/4/2024 and the latest revision occurred on 4/16/2024. Recruitment aims to enroll 120 patients from a single site."

Answered by AI

Is the second dosage level of this medication sanctioned by the FDA?

"According to our assessment at Power, Dose Level 2 has been rated a safety score of 1 on the scale from 1 to 3. This rating is attributed to the preliminary nature of this Phase I trial with limited evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Sovilnesib in Subjects With Ovarian Cancer

2024. "A Study of Sovilnesib in Subjects With Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06084416.