← Back to Search

Other

DSP-0390 for Brain Tumor

Phase < 1
Recruiting
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
KPS >=70%
Recovery from toxic effects of prior therapy to NCI CTCAE v5.0 Grade 1 (non-hematologic toxicities) or Grade <=2 (hematologic toxicities, except deep vein thrombosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 and cycle 2 day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days
Awards & highlights

Study Summary

This trial looks at DSP-0390, a new drug, as a possible treatment for people with a certain type of brain tumor that has come back.

Who is the study for?
This trial is for adults with recurrent high-grade glioma who have a good performance status, stable organ function, and no recent major surgeries or other cancer treatments. They must not have certain heart conditions, active infections (HIV/HCV/HBV), significant eye abnormalities, uncontrolled illnesses that could affect study participation, or be on conflicting medications. Women of childbearing potential and men must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing DSP-0390 in patients with recurrent high-grade brain tumors like glioblastoma. It aims to see how effective this drug is in treating the tumor and what side effects it may cause.See study design
What are the potential side effects?
While specific side effects of DSP-0390 are not listed here, common ones for cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver issues indicated by altered blood tests results and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I have recovered from previous cancer treatment side effects.
Select...
My blood counts and organ functions are within the required ranges.
Select...
My epilepsy medication dose has been stable and I've had no seizures for 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 and cycle 2 day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs, each cycle is 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 and cycle 2 day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs, each cycle is 28 days 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 Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma
Dose Escalation: Assess safety of DSP-0390 by severity of TEAEs and SAEs in adult patients with recurrent high-grade glioma
Dose Escalation: Determine the MTD and/or RDE of DSP-0390
+3 more
Secondary outcome measures
Dose Escalation: Characterize the PK profile for AUC
Dose Escalation: Characterize the PK profile for Cmax
Dose Escalation: Characterize the PK profile for Racc
+3 more
Other outcome measures
Exploratory: Assess the PD effect of DSP-0390

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm DSP-0390Experimental Treatment1 Intervention
Arm Description [*] DSP-0390 by oral administration

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,722 Total Patients Enrolled
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,589 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,910 Total Patients Enrolled

Media Library

DSP-0390 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05023551 — Phase < 1
Brain Tumor Research Study Groups: Single arm DSP-0390
Brain Tumor Clinical Trial 2023: DSP-0390 Highlights & Side Effects. Trial Name: NCT05023551 — Phase < 1
DSP-0390 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05023551 — Phase < 1

Frequently Asked Questions

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

How extensive is the subject population for this medical trial?

"Affirmative. Data hosted on clinicaltrials.gov verifies that recruitment for this medical trial is currently ongoing; the study was first announced in September 2021, with its information last refreshed during October 2022. The research requires 70 test subjects to be sourced from 6 separate centres."

Answered by AI

Are there currently any opportunities for patients to participate in this medical trial?

"This clinical trial, which is documented on clinicaltrials.gov and was initially posted on September 8th 2021, is actively looking for participants. In fact the study has been updated most recently in October 28th 2022."

Answered by AI

What are the objectives of this research endeavor?

"According to the trial's sponsor, Sumitomo Dainippon Pharma Oncology, Inc., this research project seeks to measure its primary outcome over a 6-month timeframe by performing radiologic examinations at 8 week intervals. The primary objective of these assessments is ascertaining the safety of the Recommended Phase 2 Dosage through gauging toxicity and adverse events. Additionally, secondary outcomes such as PK profiles for Racc, AUC and Cmax will be studied."

Answered by AI

How many facilities are managing this experiment?

"Washington University School of Medicine in Saint Louis, Missouri, Huntsman Cancer Institute, University of Utah in Salt Lake City, Utah and Columbia University in New york, New York are just some of the clinical trial sites enrolling patients. There are 6 more locations that are also participating."

Answered by AI
~13 spots leftby Nov 2024