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A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma


Inclusion Criteria:



- Able to provide signed and dated informed consent prior to study-specific screening
procedures.

- Histologically or cytologically confirmed leiomyosarcoma that is persistent,
recurrent or metastatic.

- Measurable disease as defined by RECIST.

- Karnofsky performance status >= 70%

- Male or female patients of child-producing potential must agree to use contraception
or avoidance of pregnancy measures during the study and for 30 days after the last
infusion of ARQ 501.

- Hemoglobin (Hgb) >= 10 g/dL.

- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1,500/mm3).

- Platelet count >= 100 x 10^9/L (>= 100,000/mm3).

- Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than
or equal to 3.0 x ULN with metastatic liver disease.

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or
equal to 2.5 x ULN less than or equal to 5.0 ULN with metastatic liver disease.

- Creatinine less than or equal to 1.5 x ULN.

Exclusion Criteria:

- Received three or more prior anticancer chemotherapy regimens.

- Have active, uncontrolled systemic infection considered opportunistic, life
threatening or clinically significant at the time of treatment.

- Have received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or
investigational agents within four weeks of first infusion.

- Have symptomatic or untreated central nervous system (CNS) involvement.

- Are pregnant or breastfeeding.

- Previous exposure to ARQ 501.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Authority:

United States: Food and Drug Administration

Study ID:

ARQ 501-221

NCT ID:

NCT00310518

Start Date:

February 2006

Completion Date:

July 2007

Related Keywords:

  • Cancer
  • Leiomyosarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
City of Hope Medical CenterDuarte, California  91010
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Premiere OncologySanta Monica, California  90404
Premiere Oncology of ArizonaScottsdale, Arizona  85260