Return to List

Study Summary
No. 2008-0046:.......Leukemia......Jorge Cortes......Leukemia
.
Study Summary Title
Study Summary
Number:
2008-0046
Study Title: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 (AP24534-07-101)
.
Physician New Patient Referral
Name:Jorge CortesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-5783
Contact us about clinical trials
.
General Information
Disease Group:LeukemiaSupported By:ARIAD Pharmaceuticals, Inc.
Phase of Study:Phase IReturn
Visit:
Weekly during cycle 1, every 2 weeks on cycle 2, then every 4 weeks.
Treatment
Agents:
AP24534Home Care:AP24534 is self administered.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
None anticipated; however, will admit to hematology beds if the patient is
admitted for adverse reactions or suspected side effects from this new agent
Description/
Intervention:
The goal of this clinical research study is to find the highest tolerable dose
of AP24534 that can be given to patients with blood cancer that has not
responded to standard treatments, or for which standard treatments are
currently not available. The safety of this drug will also be studied.

AP24534 is in the early stages of being tested in humans.
.
Study Objectives / Outcomes
Primary
The primary objective 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 (CML) and other refractory hematologic malignancies.

Secondary
Secondary objectives are:
  • To examine the safety and tolerability of AP24534 in patients with resistant/refractory hematologic malignancies
  • To examine the anti-tumor activity of AP24534 in patients with refractory hematologic malignancies
  • To examine the pharmacokinetics of AP24534
  • To examine the pharmacodynamic activity of AP24534 in CML and Ph+ ALL patients
  • To describe potential pharmacogenomic markers of AP24534 anti-tumor activity
.
Study Status Information
Study Activation / Registration Date:06/11/2008
IRB Review and Approval Date:05/09/2008
Study Type:Phase I
Recruitment Status:Open
Projected Accrual:50
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Male or female patient >/= 18 years old

2) 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. Hematologic malignancies include any phase of chronic myelogenous leukemia (CML) or myeloproliferative disorders; acute myelogenous leukemia (AML); acute lymphoblastic leukemia (ALL), especially patients with Bcr-Abl rearrangement (Philadelphia chromosome positive [Ph+]); myelodysplastic syndrome (MDS); multiple myeloma; chronic lymphocytic leukemia (CLL).

3) Able to give written informed consent

4) ECOG performance status </= 2

5) BSA >/= 1.5 m(2) (first cohort only)

6) Minimum life expectancy of 3 months or more

7) Adequate renal function defined as: serum creatinine < 1.5x upper limit of normal (ULN) for institution

8) Adequate hepatic function defined as: Total bilirubin < 1.5 x ULN for institution; ALT and AST < 2.5 x ULN for institution (<5 x ULN if liver involvement with leukemia); Prothrombin time < 1.5 x ULN

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

10) Adequate cardiac function defined as ejection fraction (EF) > 40% by any method of the Investigator's choice

11) Normal QTcF interval on screening ECG evaluation, defined as QTcF of < 450 ms

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

13) 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:1) Received cytotoxic chemotherapy or radiotherapy within 21 days (or 42 days for nitrosoureas or mitomycin C) prior to entering the study, or have not recovered (> Grade 1 by CTCAE v. 3) from adverse events (except alopecia) due to agents administered more than 28 days earlier

2) Received an investigational agent within 14 days of starting AP24534

3) Malabsorption syndrome or other illness that could affect oral absorption

4) Significant uncontrolled cardiac disease

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

6) Uncontrolled hypertension (Diastolic BP > 100 mm Hg; Systolic > 150 mm Hg)

7) Uncontrolled intercurrent illness including, but not limited to the following: ongoing or active infection, uncontrolled seizure disorder, psychiatric or social circumstances that would limit compliance with study requirements

8) Pregnant. Pregnant women are excluded from this study because the teratogenic or abortifacient effects of AP24534 are not known at this time. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AP24534, breastfeeding should be discontinued if the mother is treated with AP24534

9) Known infection with HIV

10) Autologous or allogeneic stem cell transplant < 3 months (90 days) prior to enrollment; any evidence of on-going graft versus host disease (GVHD), or GVHD requiring immunosuppressive therapy

11) Another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)

12) Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the drug

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

.
Links
Registration Number: NCT00660920
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center