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Microtubule Inhibitor

Phase 1: ABI-009 100 mg/week for Bladder Cancer

Phase 1 & 2

Waitlist Available

Led By James McKiernan, MD

Research Sponsored by Aadi, LLC

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 end of study [eos, 3 months]

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer

Eligible Conditions

Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study [eos, 3 months]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study [eos, 3 months]

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study [eos, 3 months] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009

Phase 2: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 and Gemcitabine

Secondary study objectives

Phase 1: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 2: ABI-009 400 mg/week + Gemcitabine 2000 mg/weekExperimental Treatment2 Interventions

ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks

Group II: Phase 1: ABI-009 400 mg/weekExperimental Treatment1 Intervention

Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

Group III: Phase 1: ABI-009 300 mg/weekExperimental Treatment1 Intervention

Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

Group IV: Phase 1: ABI-009 200 mg/weekExperimental Treatment1 Intervention

Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

Group V: Phase 1: ABI-009 100 mg/weekExperimental Treatment1 Intervention

Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

Group VI: Phase 1: ABI-009 100 mg 2×/weekExperimental Treatment1 Intervention

Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

FDA approved

Gemcitabine

FDA approved

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