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NCT02016729 Clinical Trial

A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia

Cancer Clinical Trial

Official title:
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02016729
Other study ID # 20120234
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 1, 2014
Est. completion date July 31, 2017

Study information
Verified date February 2019
Source Kartos Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date July 31, 2017
Est. primary completion date April 19, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men or women > 18 years old

- Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy

- Ability to take oral medications and willing to record daily adherance to investigational product

- Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

- Active infection requiring intravenous (IV) antibiotics

- Prior participation in an investigational study (procedure or device) within 21 days of study day 1

- Major surgery within 28 days of study day 1

- Anti-tumor therapy within 14 days of study day 1

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AMG 232
Given an an oral tablet in escalating doses.
• Trametinib
Trametinib is an oral tablet given in a fixed dose.

Locations
Country Name City State
United States Research Site Birmingham Alabama
United States Research Site Buffalo New York
United States Research Site Charlotte North Carolina
United States Research Site Salt Lake City Utah
United States Research Site Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Kartos Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and tolerability of AMG 232 To evaluate the safety and tolerability of AMG 232 by reviewing clinically significant or = Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled. 36 months
Primary Characterize the pharmacokinetics of AMG 232 alone and in combination with trametinib when administered orally. PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax). 36 months
Primary Determine the maximum tolerated dose of AMG 232 alone and in combination with trametinib, if possible. The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in < 33% of subjects enrolled in a cohort. 36 months
Secondary Treatment Response Complete response (CR), complete response with incomplete recovery (CRi), and duration response. 36 months
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