Clinical trial NCT00322673: Study of XL999 in Patients With Acute Myeloid Leukemia (AML)
Official title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
AML
Keywords: acute myeloid leukemia
AML
Lead sponsor: Symphony Evolution, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL999 when given weekly to patients with relapsed or newly-diagnosed AML. XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR, c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (except AML FAB-M3 or acute promyelocytic leukemia \[APL\]) based on the World Health Organization (WHO) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)
* ECOG performance status of 0 or 1
* Subjects with newly-diagnosed AML or subjects with relapsed AML after at least 2 chemotherapy regimens.
* Adequate liver and renal function
* Signed informed consent

Exclusion Criteria:

* Anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of XL999 treatment
* Hematopoietic stem cell transplantation within the previous 6 weeks
* Immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (GvHD) within 30 days prior to the start of XL999
* The subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered \> 4 weeks prior to study enrollment
* Uncontrolled and/or concomitant illness
* Pregnant or breastfeeding females
* Known HIV

Primary outcomes:
measure: Hematologic and cytogenetic response rate
timeFrame: Inclusion until disease progression
measure: Safety and tolerability
timeFrame: Inclusion until 30 dyas post last treatment
Secondary outcomes:
measure: Duration of hematologic response and transfusion independence
timeFrame: Inclusion until disease progression
measure: Progression-free survival
timeFrame: Inclusion until disease progression
measure: Overall survival
timeFrame: Inclusion until 180-day Follow-up post last treatment or death
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: Eddie Hu
state: California
city: Los Angeles
country: United States
facility: Ronald Paquette
state: California
city: Northridge
country: United States
facility: The Thomas and Dorothy Leavey Cancer Center
state: California
city: Redondo Beach
country: United States
facility: David Chan
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology
state: Illinois
city: Indianapolis
country: United States
facility: American Health Network of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Section of Hematology/Oncology Indiana Cancer Pavilion
state: Indiana
Study officials:
affiliation: Exelixis
name: Lynne Bui, MD
role: STUDY_DIRECTOR
References: