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BCL-2 Inhibitor

AMG 176 + Azacitidine for Myelodysplastic Syndrome/Chronic Myelomonocytic Leukemia

Phase 1

Waitlist Available

Research Sponsored by Amgen

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 up to 1.5 years

Awards & highlights

Study Summary

This trialtests a new drug to treat HR-MDS/CMML, to see if it is safe, tolerable and effective.

Who is the study for?

This trial is for adults with higher-risk myelodysplastic syndrome (HR-MDS) or chronic myelomonocytic leukemia (CMML) who have not responded to, or have relapsed after, treatments including azacitidine. It's also open to those newly diagnosed with HR-MDS if they haven't started treatment yet. People can't join if they've had certain other cancers recently, low-risk MDS by IPSS-R score, CMML-0, or are suitable for intensive salvage therapy.Check my eligibility

What is being tested?

The trial is testing AMG 176 alone and combined with a drug called azacitidine in patients with HR-MDS/CMML. The goal is to see how safe and effective these treatments are when given together compared to when they're given separately.See study design

What are the potential side effects?

Possible side effects of AMG 176 and azacitidine may include nausea, vomiting, fatigue, injection site reactions for azacitidine since it's often injected under the skin or into the vein, and potential blood cell count changes leading to anemia or increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1A and 1B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

Part 1A and 1B: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Part 2: Overall Response Rate (ORR)

Secondary outcome measures

Part 1A and Part 1B: Overall Response

Part 1A and Part 1B: Time to Response (TTR)

Part 1A, Part 1B and Part 2: Duration of Response (DoR)

+16 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2 - AMG 176 and Azacitidine Combination Therapy (Dose Expansion)Experimental Treatment2 Interventions

After the completion of Part 1, the Part 2 dose expansion phase will begin at the OBD/MSBED identified in Part 1. Venetoclax-naïve and venetoclax-exposed R/R HR-MDS participants after HMA failure will be enrolled along with participants with newly diagnosed HR-MDS/CMML.

Group II: Part 1B - AMG 176 and Azacitidine Combination Therapy (Dose Exploration)Experimental Treatment2 Interventions

After the OBD is found in Part 1A, two dose levels of AMG 176 in combination with azacitidine will be tested in Part 1B to find the OBD/MSBED.

Group III: Part 1A - AMG 176 Monotherapy (Dose Exploration)Experimental Treatment1 Intervention

Two dose levels of AMG 176 will be tested in Part 1A to find the optimal biological dose/minimum safe biologically effective dose (OBD/MSBED).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

AMG 176

2022

Completed Phase 1

~10

Do I qualify?Apply below to find out

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Who is running the clinical trial?

AmgenLead Sponsor

1,370 Previous Clinical Trials

1,377,679 Total Patients Enrolled

MDStudy DirectorAmgen

913 Previous Clinical Trials

924,122 Total Patients Enrolled

Media Library

Chronic Myelomonocytic Leukemia Research Study Groups: Part 1B - AMG 176 and Azacitidine Combination Therapy (Dose Exploration), Part 1A - AMG 176 Monotherapy (Dose Exploration), Part 2 - AMG 176 and Azacitidine Combination Therapy (Dose Expansion)

Frequently Asked Questions

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

Does the trial accept participants who have surpassed four decades of life?

"For this clinical trial, the accepted age range for participants is 18 to 85 years old."

Answered by AI

Who has been granted access to participate in this clinical research?

"This clinical trail is searching for 120 individuals suffering from leukimia, myelomonocytic and chronic illnesses to participate. Patients must between 18 and 85 years of age in order to be accepted into the trial."

Answered by AI

What is the upper-bound of individuals participating in this clinical exploration?

"Affirmative. Clinicaltrials.gov has the information indicating that this trial is presently looking for qualified candidates, and was incepted on November 15th 2022 with a recent update occurring just last week on November 22nd 2022. The study requires 120 volunteers from one medical facility."

Answered by AI

Has the FDA given their sanction to study the efficacy of a conjoint treatment with AMG 176 and Azacitidine?

"There is limited data to support the safety and efficacy of Part 1B - AMG 176 in conjunction with Azacitidine Combination Therapy (Dose Exploration) so a score of one was given."

Answered by AI

Is this trial actively looking for volunteers?

"Affirmative. The clinicaltrials.gov database indicates that this medical trial, which was first published on November 15th 2022, is still actively enrolling patients. Approximately 120 people must be enrolled at 1 study site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia

2022. "AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05209152.