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CDK Inhibitor

Onalespib + CDKI AT7519 for Advanced Cancer

Phase 1
Waitlist Available
Led By Khanh T Do
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Kidney function requirements: Creatinine < 1 X institutional upper limit of normal OR creatinine clearance >= 50 mL/min determined by Cockcroft-Gault formula, Creatine phosphokinase =< institutional upper limit of normal
Liver function requirements: Total bilirubin =< 1.5 X institutional upper limit of normal, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 X institutional upper limit of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before infusion, at 30 and 59 minutes of infusion, and at 1.5, 2, 4, 6, 8, and 24 hours at end of infusion on day 1 of course 0 and days 1 and 11 of course 1
Awards & highlights

Study Summary

This trial is testing onalespib and CDKI AT7519 to see what effects (good and bad) they have on patients with solid tumors that have spread or cannot be removed by surgery.

Who is the study for?
This trial is for adults with solid tumors that have spread or can't be surgically removed, and who've recovered from previous treatments (except hair loss). They should not be pregnant, must use birth control, and have a life expectancy over 3 months. Participants need normal organ function tests and measurable disease by certain medical imaging standards.Check my eligibility
What is being tested?
The study is testing the safety and optimal dosages of two drugs, Onalespib and CDKI AT7519, in patients with advanced solid tumors. These drugs are believed to inhibit enzymes necessary for tumor cell growth. The trial will also analyze biomarkers in the lab to understand how these drugs work.See study design
What are the potential side effects?
Potential side effects include reactions related to blocking enzymes needed for cell growth which may affect various organs. Specific risks are unknown but could involve eye toxicity, heart issues like reduced heart pump function or arrhythmias, nerve damage manifesting as numbness or tingling in extremities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the normal range.
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My liver tests are within the normal range.
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I am fully active or can carry out light work.
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My cancer has spread, cannot be surgically removed, and standard treatments are not effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before infusion, at 30 and 59 minutes of infusion, and at 1.5, 2, 4, 6, 8, and 24 hours at end of infusion on day 1 of course 0 and days 1 and 11 of course 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and before infusion, at 30 and 59 minutes of infusion, and at 1.5, 2, 4, 6, 8, and 24 hours at end of infusion on day 1 of course 0 and days 1 and 11 of course 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events of onalespib and CDKI AT7519
Maximum tolerated dose of onalespib and CDKI AT7519
Tolerability of onalespib and CDKI AT7519
Secondary outcome measures
Antitumor activity of the combination
Pharmacodynamic (PD) parameters of onalespib and CDKI AT7519
Pharmacokinetic parameters of onalespib and CDKI AT7519

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (onalespib, CDKI AT7519)Experimental Treatment4 Interventions
Patients receive onalespib IV over 1 hour on days 1 and 4 (cycle 0 only). Patients then receive onalespib IV over 1 hour and CDKI AT7519 IV over 1 hour on days 1, 4, 8, and 11 (cycle 1 and subsequent cycles thereafter). Cycles repeat every 21 days (7 days for course 0 only) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onalespib
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,334 Total Patients Enrolled
Khanh T DoPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

Media Library

CDKI AT7519 (CDK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02503709 — Phase 1
Cancer Research Study Groups: Treatment (onalespib, CDKI AT7519)
Cancer Clinical Trial 2023: CDKI AT7519 Highlights & Side Effects. Trial Name: NCT02503709 — Phase 1
CDKI AT7519 (CDK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02503709 — Phase 1
~3 spots leftby Jun 2025
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