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A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerability and Maximum Tolerated Dose of Oral AP24534 in Patients With Refractory or Advanced Chronic Myelogenous Leukemia and Other Hematologic Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Myelogenous Leukemia, Hematologic Malignancies

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Trial Information

A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerability and Maximum Tolerated Dose of Oral AP24534 in Patients With Refractory or Advanced Chronic Myelogenous Leukemia and Other Hematologic Malignancies


The purpose of this study is to determine the maximum tolerated dose or a recommended dose
of oral AP24534 in a defined schedule (QD) in patients with refractory or advanced chronic
myelogenous leukemia and other refractory hematologic malignancies.


Inclusion Criteria:



- Male or Female ≥ 18 years old

- Diagnosed hematologic malignancy (other than lymphoma) that has relapsed or is
refractory to standard care or for which no standard care is available or acceptable

- Able to give written informed consent

- ECOG performance status ≤ 2

- BSA ≥ 1.5 m² (first cohort only)

- Minimum life expectancy of 3 months or more

- Adequate renal function

- Adequate hepatic function

- Ability to comply with study procedures in the Investigator's opinion

- Adequate cardiac function

- For females of childbearing potential, a negative pregnancy test must be documented
prior to enrollment

- Female patients who are of childbearing potential must agree to use an effective form
of contraception with their sexual partners throughout participation in this study

Exclusion Criteria:

- Have had cytotoxic chemotherapy or radiotherapy within 21 days prior to entering the
study, or those who have not recovered from adverse events due to agents administered
more than 28 days earlier with the exception of alopecia

- Received any other investigational agents or have received an investigational agent
within 14 days of starting AP24534

- Malabsorption syndrome or other illness which could effect oral absorption

- Significant uncontrolled cardiac disease

- Uncontrolled hypertension

- Uncontrolled intercurrent illness

- Pregnant

- Known infection of HIV

- Autologous or allogeneic stem cell transplant < 3 months prior to enrollment; any
evidence of ongoing GVHD, or GVHD requiring immunosuppressive therapy

- Another primary malignancy within the past 3 years

- Any condition or illness which, in the opinion of the investigator, would compromise
patient safety or interfere with the evaluation of the safety of the drug

- Patients taking medicinal products that are known to be associated with prolongation
of the QT interval on the electrocardiogram

- Major surgery (with the exception of intravenous catheter placement or bone marrow
biopsy) within 14 days prior to initiating AP24534 therapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

Duration of the study

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Ariad Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

AP24534-07-101

NCT ID:

NCT00660920

Start Date:

May 2008

Completion Date:

July 2018

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Hematologic Malignancies
  • Neoplasms
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Hematologic Neoplasms

Name

Location

ARIAD Investigational Site #075San Francisco, California  94143
ARIAD Investigational Site #011Ann Arbor, Michigan  48109
ARIAD Investigational Site #048Portland, Oregon  97239
ARIAD Investigational Site #076Nashville, Tennessee  37203
ARIAD Investigational Site #005Houston, Texas  70030