First in-Human Trial of the Experimental Drug AMG 176 in Relapsed or Refractory (re-occurring) Cancer of the Blood Systems

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"This study will look at which doses of the study drug AMG 176 are safe for people to take."
Age: 18 to 85 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, cancer, cancer drug, relapsed cancer, refractory cancer
Type: Drug study, Phase 1
Target:
10 Participants
Investigator:
Description
AMG 176 is being developed by Amgen Inc., a for-profit biopharmaceutical company. AMG 176 is an experimental product and is not approved by the FDA for use in people with multiple myeloma or AML.

The purpose of this study is to find out more about AMG 176. The research team will study it in people with relapsed/ refractory multiple myeloma (MM) or relapsed/refractory AML. AMG inhibits the protein MCL1. MCL1 promotes cancer cell (myeloma and leukemia cells) survival. It prevents normal programmed cell death mechanisms. Inhibiting MCL1 with AMG176 should promote tumor cell death.

This study will see if AMG 176 is safe and whether it causes any side effects. This study will also look at what doses of AMG 176 are safe for people to take in order to find the highest dose that is safe.
This study requires

During the drug administration part of the study, you will need to attend regularly scheduled visits with your study doctor. You are to follow the directions provided to you by the research nurse or coordinator and your doctor. The Table below describes the timing of these visits. The study drug will be administered over seven cycles, each of which will last four weeks. Including the preliminary screening and follow-up visit, your involvement in the study will last approximately 7.5 months. Your participation will generally include 1-2 visits per week, each of which will last 4-8 hours. It is important that you inform your study doctor of any illnesses that occur, and any medications (prescription or over the counter) that you take during your participation in this study. You will be asked not to participate in any other clinical trials involving any other investigational product (study drug or device) while you are in the treatment part of this study. You will also be asked not to receive any other chemotherapy or anti-tumor therapy for your cancer while you are being treated. In addition, you will not be allowed to schedule any elective surgeries during the treatment part of the study.

If you are a multiple myeloma (MM) subject and participate in Part 1a, 1b or 2 and complete the entire study, the total amount of blood collected from you will be approximately 34 tablespoons (450 mL). If you are an AML subject and participate in Part 3 and complete the entire study, the total amount of blood collected from you will be approximately 28 tablespoons (365 mL). More blood may be collected from you if additional follow-up is needed for your safety. These samples will be used to monitor your safety, the amount of AMG 176 in your blood and the effects of AMG 176. This blood collection will also be used for Biomarker Development. These samples can be used to learn more about cancer or mechanism of action/target (ie, how the drug works). You can ask the study doctor or the study staff about the tests listed in the study protocol. The study doctor may ask you to come back for additional safety tests after the end of the study.

During the drug administration part of the study, you will need to attend regularly scheduled visits with your study doctor. You are to follow the directions provided to you by the research nurse or coordinator and your doctor. The Table below describes the timing of these visits.

The study drug will be administered over seven cycles, each of which will last four weeks. Your participation will generally include 1-2 visits per week, each of which will last 4-8 hours.

VISIT SCHEDULE  - Screening occurs Once.

  • Day 1 occurs Once at each cycle.

  • Drug administration occurs One or two days, every week for 3 weeks each cycle, the number of days depends on which part of the study you are assigned to. 

  • Each Cycle occurs Every 4 weeks.

  • End of Treatment occurs Once.

- End of Study Safety follow-up occurs 21 to 28 days after last dose of study drug.

If you are a multiple myeloma (MM) subject and participate in Part 1a, 1b or 2 and complete the entire study, the total amount of blood collected from you will be approximately 34 tablespoons (450 mL).

If you are an AML subject and participate in Part 3 and complete the entire study, the total amount of blood collected from you will be approximately 28 tablespoons (365 mL).

More blood may be collected from you if additional follow-up is needed for your safety. These samples will be used to monitor your safety, the amount of AMG 176 in your blood and the effects of AMG 176. This blood collection will also be used for Biomarker Development. These samples can be used to learn more about cancer or mechanism of action/target (ie, how the drug works).

You can ask the study doctor or the study staff about the tests listed in the study protocol. The study doctor may ask you to come back for additional safety tests after the end of the study.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefit to you as a result of taking part in this research study. No one knows if participation in this study will help you. Your condition may get better but it could stay the same or even get worse. The information from this study might help in the development of additional treatments in the future for cancer.

RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be compensated for your participation in this study.
Resources
Schedule
Study duration and period
Your involvement in the study will last approximately 7.5 months.
Recruitment period
From March 21, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Relapsed or Refractory Multiple Myeloma
  • Relapsed or Refractory Acute Myeloid Leukemia

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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