Safety Study of AP24534 to Treat Chronic Myelogenous Leukemia (CML) and Other Hematological Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ariad Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00660920
First received: April 15, 2008
Last updated: February 12, 2016
Last verified: February 2016

April 15, 2008
February 12, 2016
May 2008
May 2016   (final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
To determine the maximum tolerated dose or a recommended dose of oral ponatinib in a defined schedule (QD) in patients with refractory or advanced chronic myelogenous leukemia and other refractory hematologic malignancies.
Maximum Tolerated Dose (MTD) [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00660920 on ClinicalTrials.gov Archive Site
  • To examine the safety of AP24534 in patients with resistant/refractory hematologic malignancies [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
  • To describe the anti-tumor activity of AP24534 in patients with refractory hematologic malignancies [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • To examine the pharmacokinetics of AP24534 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • To examine pharmacodynamic activity of AP24534 in CML and Ph + ALL patients [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • To describe potential pharmacogenomic markers of AP24534 anti-tumor activity [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
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Safety Study of AP24534 to Treat Chronic Myelogenous Leukemia (CML) and Other Hematological Malignancies
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.
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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Myelogenous Leukemia
  • Hematologic Malignancies
Drug: Ponatinib
Comparison of different dosages of drug given orally once per day.
Other Names:
  • AP24534
  • Iclusig
Experimental: ponatnib
Comparison of different dosages of ponatinib given orally once per day.
Intervention: Drug: Ponatinib
Cortes JE, Kantarjian H, Shah NP, Bixby D, Mauro MJ, Flinn I, O'Hare T, Hu S, Narasimhan NI, Rivera VM, Clackson T, Turner CD, Haluska FG, Druker BJ, Deininger MW, Talpaz M. Ponatinib in refractory Philadelphia chromosome-positive leukemias. N Engl J Med. 2012 Nov 29;367(22):2075-88. doi: 10.1056/NEJMoa1205127.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
81
May 2016
May 2016   (final data collection date for primary outcome measure)

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 defined as serum creatinine <1.5× upper limit of normal (ULN) for institution
  • Adequate hepatic function (defined as: Total bilirubin <1.5 × ULN for institution; ALT and AST <2.5 × ULN for institution [<5 X ULN if liver involvement with leukemia]; Prothrombin time <1.5 × ULN)
  • Ability to comply with study procedures in the Investigator's opinion
  • Adequate cardiac function defined as ejection fraction (EF) >40% by any method of the investigator's choice
  • Normal QTcF interval on screening ECG evaluation, defined as QTcF of <450 ms.
  • 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 ponatinib
  • Malabsorption syndrome or other illness which could affect oral absorption
  • Significant uncontrolled cardiac disease
  • Patients taking medicinal products that are known to be associated with prolongation of the QT interval on the electrocardiogram.
  • Uncontrolled hypertension (Diastolic BP >100 mmHg; Systolic >150 mmHg)
  • Uncontrolled intercurrent illness
  • Pregnant
  • Known infection with HIV
  • Autologous or allogeneic stem cell transplant < 3 months prior to enrollment; any evidence of ongoing graft versus host disease (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 ponatinib therapy
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00660920
AP24534-07-101
No
Not Provided
Not Provided
Ariad Pharmaceuticals
Ariad Pharmaceuticals
Not Provided
Not Provided
Ariad Pharmaceuticals
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP