Part 1B - AMG 176 and Azacitidine Combination Therapy (Dose Exploration) for Chronic Myelomonocytic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas MD Anderson Cancer Center, Houston, TXChronic Myelomonocytic Leukemia+1 MoreAzacitidine - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome (MDS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 19 Secondary · Reporting Duration: Up to 1.5 years

Day 23
Part 1A: Area Under the Concentration-time Curve (AUC) of AMG 176 when Administered as Monotherapy
Part 1A: Clearance (CL) of AMG 176 when Administered as Monotherapy
Part 1A: Half-life (t1/2) of AMG 176 when Administered as Monotherapy
Part 1A: Maximum Concentration (Cmax) of AMG 176 when Administered as Monotherapy
Part 1B and Part 2: AUC of AMG 176 when Administered in Combination
Part 1B and Part 2: CL of AMG 176 when Administered in Combination
Part 1B and Part 2: Cmax of AMG 176 when Administered in Combination
Part 1B and Part 2: T1/2 of AMG 176 when Administered in Combination
Day 23
Part 1B and Part 2: AUC of Azacitidine when Administered in Combination
Part 1B and Part 2: CL of Azacitidine when Administered in Combination
Part 1B and Part 2: Cmax of Azacitidine when Administered in Combination
Part 1B and Part 2: T1/2 of Azacitidine when Administered in Combination
Day 28
Part 1A and 1B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Up to 1.5 years
Part 1A and 1B: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
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)
Part 1A, Part 1B and Part 2: Event-free Survival (EFS)
Part 2: Overall Response Rate (ORR)
Part 2: Overall Survival (OS)
Part 2: Time to Next MDS Treatment (TTNT)
Part 2: Time to Transformation to Acute Myeloid Leukemia (AML)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Part 1B - AMG 176 and Azacitidine Combination Therapy (Dose Exploration)
1 of 3
Part 1A - AMG 176 Monotherapy (Dose Exploration)
1 of 3
Part 2 - AMG 176 and Azacitidine Combination Therapy (Dose Expansion)
1 of 3

Experimental Treatment

120 Total Participants · 3 Treatment Groups

Primary Treatment: Part 1B - AMG 176 and Azacitidine Combination Therapy (Dose Exploration) · No Placebo Group · Phase 1

Part 1B - AMG 176 and Azacitidine Combination Therapy (Dose Exploration)Experimental Group · 2 Interventions: Azacitidine, AMG 176 · Intervention Types: Drug, Drug
Part 1A - AMG 176 Monotherapy (Dose Exploration)
Drug
Experimental Group · 1 Intervention: AMG 176 · Intervention Types: Drug
Part 2 - AMG 176 and Azacitidine Combination Therapy (Dose Expansion)Experimental Group · 2 Interventions: Azacitidine, AMG 176 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1.5 years

Who is running the clinical trial?

AmgenLead Sponsor
1,301 Previous Clinical Trials
1,330,050 Total Patients Enrolled
MDStudy DirectorAmgen
843 Previous Clinical Trials
899,343 Total Patients Enrolled

Eligibility Criteria

Age 18 - 85 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.