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ATI-2231 for Solid Tumor Cancers
Phase 1
Waitlist Available
Led By Cynthia X Ma, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
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 pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Awards & highlights
Summary
This trial is testing a new drug called ATI-2231 in patients with serious types of cancer to determine the most effective dose.
Eligible Conditions
- Solid Tumors
- Solid Tumor Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants experiencing adverse events
Secondary outcome measures
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Changes in ATI-2231 pharmacokinetics (PK) as measured by apparent clearance
Changes in ATI-2231 pharmacokinetics (PK) as measured by apparent volume of distribution
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ATI-2231 monotherapy dose escalationExperimental Treatment1 Intervention
Patients will receive single agent ATI-2231 at assigned dose levels (n=3-6 per dose level). Starting dose of 20 mg by mouth twice per day.
Each cycle is 21 days
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Who is running the clinical trial?
United States Department of DefenseFED
875 Previous Clinical Trials
329,986 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,558 Total Patients Enrolled
Aclaris Therapeutics, Inc.Industry Sponsor
32 Previous Clinical Trials
4,862 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to drugs similar to ATI-2231 or other drugs being used in the study.For the capecitabine cohort, you must have completed a 3-week washout period from any prior chemotherapy other than capecitabine and completely recovered all adverse events (AEs) to Grade 1 (except alopecia).You have abstained from previous chemotherapy for three weeks or a sufficient amount of time has elapsed since your last dose that any adverse effects have been reduced to Grade 1 (excluding hair loss).Your absolute neutrophil count is at least 1,500/mcL.Your AST(SGOT)/ALT(SGPT) ratio is less than or equal to 3.0 times your individual upper limit of normal (IULN).Women of childbearing potential and men in heterosexually active relationships must agree to use effective contraception throughout the trial period, with women continuing it for up to a month after treatment completion and men extending that period by an additional two monthsYou have a biopsy-confirmed advanced solid tumor malignancy with resistant characteristics.You have biopsy-confirmed hormone receptor-positive, HER2 negative metastatic breast cancer with or without bone metastases according to ASCO/CAP guidelines.You are eligible to begin capecitabine treatment as per a physician's decision and prior endocrine therapy involving CDK4/6 inhibitors.You are currently taking part in another study that involves experimental drugs.You are planning to initiate, or currently taking stable doses of capecitabine with a minimum dosage of 1000 mg/m2 twice daily for 14 days followed by 7 days off.You are at least 18 years of age.Your disease is either measurable or can be assessed according to Response Evaluation Criteria in Solid Tumors version 1.1.You have had cancer in the past, except for cancers that were treated completely at least 2 years ago and you have no signs of the cancer returning. (This only applies to Phase II of the trial.)A waiting period of one week is necessary after the completion of radiation treatment.Your ECOG performance status is 2 or lower.You have a prognosis of surviving for at least 12 weeks.You possess satisfactory bone marrow and organ functioning as outlined below.You possess the capability to comprehend and are agreeable to signing a written informed consent document sanctioned by an IRB (or that of legally authorized representative, if applicable).A 4-week gap must have elapsed since taking denosumab and zoledronic acid before beginning the study treatment, even for those who were previously enrolled in the Phase II trial.To be eligible for the Phase II study, patients must have already received at least 6 months of therapy with bisphosphonate or denosumab to treat bone metastasis.Your platelet count is above 100,000/mcL.Your creatinine clearance is greater than 60 mL/min by Cockcroft-Gault.You have biopsy-confirmed hormone receptor-positive, HER2 negative metastatic breast cancer with evidence of progression in bone lesions as seen on the most recent imaging studies.You have had no more than one prior chemotherapy regimen for metastatic disease, with no limits on endocrine therapy-based regimens.You have at least 3,000 leukocytes per microliter of blood.Your total bilirubin is no more than 1.5 times the upper limit of normal.
Research Study Groups:
This trial has the following groups:- Group 1: ATI-2231 monotherapy dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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