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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT01549548
Other study ID # IRB00008238
Secondary ID
Status No longer available
Phase N/A
First received March 6, 2012
Last updated March 13, 2013

Study information

Verified date March 2013
Source OHSU Knight Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

The main purpose of this protocol is to provide expanded access to the study drug (Ponatinib/AP24534) for people with imatinib-, dasatinib-, and nilotinib- resistant/intolerant Philadelphia Chromosome Positive (Ph+) Leukemias. The other purpose of this protocol is to monitor the safety of the study drug in people with Ph+ Leukemias that have not responded to prior treatment.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Signed and dated informed consent

- Cytogenetic or PCR-based diagnosis of any phase of Ph+ acute lymphoblastic leukemia (ALL) and documented resistance or intolerance to imatinib and a second TKI (nilotinib, dasatinib, bosutinib)

- Eastern Cooperative Oncology Group(ECOG) performance status of 0-2

- Washout from prior anti-proliferative or anti-leukemia treatment: 3 days for hydroxyurea/anagrelide and tyrosine kinase inhibitors

- < Grade 2 or baseline recovery from prior therapy related toxicities (except alopecia)

- At least 3 months post allogeneic stem cell transplantation

- Able to take oral capsules reliably

- AST/ALT less than or equal to 2.5 times ULN, or less than 5 times ULN if attributable to involvement of leukemia

- No active clinical or radiographic pancreatitis

- At least 18 years of age

- Willingness of male and female subjects to use reliable methods of birth control (when applicable)

Exclusion Criteria:

- Subjects with Philadelphia Chromosome and BCR-ABL-negative chronic myeloid leukemia (CML)

- Major surgery or radiotherapy within 7 days before the first dose of Ponatinib (recovery from any previous surgery should be complete before day 1)

- Clinically significant active/uncompensated or uncontrolled cardiac disease (active congestive heart failure; uncontrolled angina or hypertension; myocardial infarction in the past 3 months; clinically significant untreated ventricular arrhythmia; diagnosed or suspected congenital or acquired prolonged QT syndrome; unexplained syncope; history of prolonged QTc)

- Prolonged QTc (> 0.48 sec)

- Pregnant or breastfeeding women

- Evidence of serious active infection, or significant medical or psychiatric illness

- Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, or clinically significant abnormal lab finding that would, in the investigator's judgment, make the subject inappropriate for this study

- Prior resistance to Ponatinib

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
Ponatinib
Patients will receive Ponatinib 45 mg by mouth as a single daily dose on an empty stomach (no food 2 hours prior to and after dosing) on day 1 and continuous once-daily dosing everyday thereafter. Each patient will receive daily Ponatinib until disease progression, unacceptable toxicity, or withdrawal of consent.

Locations

Country Name City State
United States OHSU Knight Cancer Institute Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
OHSU Knight Cancer Institute Ariad Pharmaceuticals

Country where clinical trial is conducted

United States, 

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