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DNA Alkylating Agent

OBI-3424 for Solid Cancers

Phase 1 & 2
Recruiting
Led By Apostolia Tsimberidou, MD, PHD
Research Sponsored by OBI Pharma, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Acceptable hematologic status (without hematologic support, other than red blood cell transfusion): ANC ≥1500 cells/μL, Platelet count ≥100,000/μL, Hemoglobin ≥9.0 g/dL (prior packed red blood cell transfusion or erythropoietin support is allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 and 8 of cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective.

Who is the study for?
Adults with advanced solid tumors, including pancreatic adenocarcinoma, who have recovered from previous treatments and are in relatively good health (ECOG status 0 or 1). They must have measurable disease, acceptable organ function tests, and agree to use effective contraception. Excluded are those with certain recent treatments or surgeries, active infections requiring systemic therapy, brain metastases not well controlled, hepatocellular carcinoma (for Expansion Phase), among other criteria.Check my eligibility
What is being tested?
The trial is testing OBI-3424 as a single agent for treating advanced solid tumors. It's an early-phase study assessing the drug's safety profile, maximum tolerated dose/recommended phase two dose (MTD/RP2D), how the body processes it (pharmacokinetics/PK), and its preliminary effectiveness against cancer.See study design
What are the potential side effects?
While specific side effects of OBI-3424 aren't listed here due to it being a first-in-human study, common side effects for cancer drugs can include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems; liver enzyme alterations; allergic reactions; kidney function changes; and potential fertility impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My blood counts meet the required levels for treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver function tests are within the required range.
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My kidneys work well enough (creatinine clearance over 30 mL/min).
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I have recovered from previous treatment side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 and 8 of cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle)
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 and 8 of cycle 1 (first cycle of 34 cycles and there are 21 days for each cycle) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess safety changes in electrocardiogram (ECG)
Assess safety changes of body weight.
Define the Recommended Phase 2 Dose (RP2D)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose escalation phaseExperimental Treatment1 Intervention
OBI-3424 (1.0 mg/m^2 to 14.0 mg/m^2) will be administered by IV infusion on Days 1 and 8 of each 21-day cycle or Day 1 of each 21-day cycle to determine the MTD and RP2D with a classic 3+3 dose escalation design.
Group II: Cohort expansion phaseExperimental Treatment1 Intervention
OBI-3424 (12 mg/m^2) will be administered by IV infusion on Day 1 of each 21-day cycle.

Find a Location

Who is running the clinical trial?

OBI Pharma, IncLead Sponsor
7 Previous Clinical Trials
1,310 Total Patients Enrolled
Apostolia Tsimberidou, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

OBI-3424 (DNA Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03592264 — Phase 1 & 2
Pancreatic Adenocarcinoma Research Study Groups: Cohort expansion phase, Dose escalation phase
Pancreatic Adenocarcinoma Clinical Trial 2023: OBI-3424 Highlights & Side Effects. Trial Name: NCT03592264 — Phase 1 & 2
OBI-3424 (DNA Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03592264 — Phase 1 & 2

Frequently Asked Questions

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

Are there any opportunities to join this medical experiment currently available?

"The details on clinicaltrials.gov suggest that this medical trial is taking applications from patients, having first been posted on June 7th 2018 and most recently updated on October 17th 2022."

Answered by AI

Have any other research efforts included OBI-3424?

"Currently, two clinical tests are actively examining OBI-3424 with none in their final stage. The majority of trials for this drug are taking place in New Brunswick, NJ but there is a total 126 sites participating."

Answered by AI

How many healthcare facilities are participating in the clinical trial?

"Five clinical trial sites are operating for this research. These include the USC Norris Comprehensive Cancer Center in Los Angeles, Ohio State University Comprehensive Cancer Centre in Columbus and Scripps Clinic Torrey Pines La Jolla, with two other medical hubs also participating."

Answered by AI

Is this trial a pioneering endeavor in its field?

"OBI-3424 has been the subject of clinical trials since 2018, when it was initially researched by OBI Pharma. After a successful Phase 1 and 2 trial which included 104 participants in its sample size, two additional studies have been initiated across 65 cities and one nation."

Answered by AI

What is the recruitment capacity for this trial?

"To successfully initiate this medical trial, OBI Pharma Inc. must recruit a total of 104 patients that meet the inclusion criteria. The sponsor will be managing multiple sites across the United States including USC Norris Comprehensive Cancer Center in Los Angeles and Ohio State University Comprehensive Cancer Center in Columbus."

Answered by AI
~12 spots leftby Dec 2024