Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk Acute Myelogenous Leukemia (AML)

NCT01265199 | Terminated Phase 1

• 1 other identifier: AT-406-CS-002
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 6

Brief Summary

The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406 works. Side effects will also be studied in an effort to make sure that this drug is safe to take.

Conditions

Acute Myelogenous Leukemia (AML)

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of oral AT-406 in combination with daunorubicin and cytarabine.

  Determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability of AT-101.

  15 months

Secondary Outcomes (1)

• Determine the pharmacokinetic profile of AT-406 and daunorubicin and cytarabine

  15 months

Interventions

AT-406 in combination with daunorubicin and cytarabine DRUG

Oral AT-406 (capsule) given once daily on days 1-5 of induction therapy with daunorubicin 90 mg/m2 I.v. on days 1-3 and cytarabine 100 mg/m2 i.v. by continuous infusion on days 107 of induction therapy.

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or females patients ages 18 to 74
• Morphological diagnosis of untreated or relapsed non-M3 AML according to WHO diagnostic criteria who exhibit at least one poor-risk feature and are not be known to exhibit any favorable cytogenetic features or variants.
• Patients with relapsed AML and patients with prior autologous or allogeneic hematopoietic stem cell transplantations are eligible if relapse occurred following a remission of ≥ 6 months.
• Patients must have an ECOG score of ≤ 2,
• Adequate cardiac, liver and renal function.

You may not qualify if:

• Must not have any evidence of CNS leukemia.

Sponsors & Collaborators

• Ascenta Therapeutics: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (6)

Univerity of Chicago

Chicago, Illinois, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, United States

Location

Washington University at St. Louis Siteman Cancer Center

St Louis, Missouri, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Temple University at Jeanes Hospital

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

N-benzhydryl-5-(2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo(1,2-a)(1,5)diazocine-8-carboxamide; Daunorubicin; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• J. Mel Sorensen, MD

  Ascenta Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 23, 2010
• Study Start: February 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (6)