Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies Clinical Trial
Official title:
A Phase 1 Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic Malignancies
| Verified date | October 2011 |
| Source | ArQule |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is an open-label, dose escalation study of intravenous ARQ 621 administered to patients with late-stage solid tumors or hematologic malignancies.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | September 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures - A histologically or cytologically confirmed metastatic solid tumor or refractory/relapsed hematologic malignancy - Have a life expectancy of at least 12 weeks - =18 years of age - Measurable disease as defined by: - Solid Tumors: Response Evaluation Criteria in Solid Tumors - Multiple Myeloma (MM): International Uniform Response Criteria, at least one of the following: - Monoclonal protein in the plasma of =0.5 g/dL - Monoclonal protein in the urine of =0.2 g/24 hr urine collection - Serum immunoglobulin free light chain (FLC) =100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kappa to lambda FLC ratio - Malignant Lymphoma (ML): International Working Group Response Criteria - At least one site of disease =2 cm in longest diameter (a lesion =1 cm can be considered if PET positive) - Chronic Lymphocytic Leukemia (CLL): NCI Working Group Guidelines - Lymphocytosis (5 x 10^9 /L) with B-cell marker (CD19, CD20,CD23) + CD5 - High-risk characteristics (hemoglobin <10g/dL OR platelets <100 x 10^9 /L) - Acute Myelogenous Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL): only patients with bone marrow or peripheral blast count of =20% - Acute Promyelocytic Leukemia (APML): patients must be refractory to all-trans retinoic acid (ATRA) and arsenic trioxide - Chronic Myelogenous Leukemia (CML): patients in blast crisis (bone marrow or peripheral blast count =20%) may be included if refractory to prior therapy and to any therapy the investigators deems of higher priority (for example, BCR-ABL inhibitors such as imatinib mesylate [Gleevec], nilotinib [Tasigna], or dasatinib [Sprycel]) - ECOG performance status =2 - 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 ARQ 621 dose - Females of childbearing potential must have a negative serum pregnancy test - Aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 × upper limit of normal (ULN) or =5.0 × ULN with metastatic liver disease - Hemoglobin (Hgb) =10 g/dL (except in cases considered related to hematologic malignancy) - Total bilirubin =1.5 × ULN - Creatinine =1.5 x ULN (=2.0 x ULN in cases considered related to multiple myeloma) - Absolute neutrophil count =1.5 x 10^9/L (except in cases considered related to hematologic malignancy) - Platelets =100 x 10^9/L (except in cases considered related to hematologic malignancy) - Patients with hematologic malignancies who have progressed following at least two prior treatment regimens Exclusion Criteria: - Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of the first dose - In cases of hematologic malignancies, 4-week recovery from prior anticancer treatment is not required, however the patient must recover from prior treatment-related non-hematological toxicities to grade 2 or less - When required for supportive care corticosteroids or hydroxyurea may be used - Surgery within four weeks prior to the first dose - Known untreated brain metastases or leptomeningeal disease - Patients with solid tumors who were treated for brain metastases and who have shown stable disease for at least 8 weeks prior to enrollment will be allowed - Pregnant or breastfeeding - Uncontrolled concurrent illness including, but not limited to ongoing or active symptomatic infection requiring systemic therapy, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements - Patients having a history of Thrombotic thrombocytopenic purpura (TTP) or Hemolytic-uremic syndrome (HUS) or HUS spectrum will be excluded from the study |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Nevada Cancer Institute | Las Vegas | Nevada |
| United States | Translational Genomics Institute | Phoenix | Arizona |
| United States | Premiere Oncology | Santa Monica | California |
| Lead Sponsor | Collaborator |
|---|---|
| ArQule |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 621 administered intravenously. | 24 months estimated | Yes | |
| Secondary | To determine the pharmacokinetic profile of ARQ 621. | 24 months estimated | No | |
| Secondary | To determine the pharmacodynamic profile (incl. biomarkers) of ARQ 621. | 24 months estimated | No | |
| Secondary | To assess the preliminary anti-tumor activity of ARQ 621. | 24 months estimated | No |