RO7283420 for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

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 from baseline up to approximately 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, RO7283420, for safety and effects in patients with Acute Myeloid Leukemia who lack other treatment options or have not responded to existing treatments. The study will determine the safest dose and observe how the drug affects the disease.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 4 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Percentage of Participants who Achieve a Response

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part C: Dose ExpansionExperimental Treatment6 Interventions

Participants will receive the respective RP2D for Group I and Group II.

Group II: Part B: Multiple Participant Dose EscalationExperimental Treatment6 Interventions

Multiple-participant cohorts of \>= 3 participants will be enrolled for dose escalation for Group I and Group II independently. Participants will be administered a starting dose of 0.15 mg or highest dose administered in Part A. Each participant will receive up to 6, 9, and 18 cycles of treatment with RO7283420, when treated with Q3W, every-2-weeks (Q2W), or once-a-week (QW) dosing regimens, respectively to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Additionally, step-up dosing regimens with more frequent administrations of RO7283420 during cycle 1 will be evaluated.

Group III: Part A: Single Participant Dose EscalationExperimental Treatment6 Interventions

Participants from Group I will receive escalating doses of RO7283420, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1) for up to 6 cycles with a starting dose of 0.15mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Dasatinib

2012

Completed Phase 3

~2320