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Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by ArQule
Sponsor:
Information provided by (Responsible Party):
ArQule
ClinicalTrials.gov Identifier:
NCT01473095
First received: November 10, 2011
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092.


Condition Intervention Phase
Solid Tumor
Malignant Lymphoma
Drug: ARQ 092
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

Resource links provided by NLM:


Further study details as provided by ArQule:

Primary Outcome Measures:
  • Assess the safety and tolerability of ARQ 092 in subjects with advanced solid tumors and recurrent malignant lymphoma by monitoring frequency and severity of adverse events [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the pharmacokinetic profile (Cmax, AUC, and half-life) of ARQ 092 [ Time Frame: During the first 29 days of treatment for each dose level ] [ Designated as safety issue: No ]
  • Assess pharmacodynamic activity [ Time Frame: During the first 29 days of treatment ] [ Designated as safety issue: No ]
  • Determine preliminary evidence of activity as defined by RECIST v 1.1 [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks ] [ Designated as safety issue: No ]
  • Determine recommended Phase 2 dose [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: November 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ARQ 092
    Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women ≥18 years old
  2. Histologically or cytologically documented, incurable, locally advanced or metastatic solid tumors or recurrent malignant lymphoma in subjects who failed standard therapy or for whom standard or curative therapy does not exist or is not tolerable.
  3. Evaluable or measurable disease
  4. Life expectancy greater than three months
  5. ECOG performance status ≤2
  6. Hemoglobin (Hgb) ≥9.5 g/dl
  7. Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
  8. Platelet count ≥75 x 10^9/L
  9. Total bilirubin ≤1.5 × upper limit of normal (ULN)
  10. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 × ULN
  11. Serum creatinine ≤1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for subjects with creatinine levels >1.5 x ULN
  12. Agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug

Exclusion Criteria:

  1. History of Type 1 or 2 diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose ≥160 mg/dL at the prestudy visit. If a diabetic cohort is enrolled, only subjects with a medical history of controlled Type 1 or 2 diabetes mellitus will be enrolled in the cohort.
  2. Grade 2 or worse hypercholesterolemia or hypertriglyceridemia or >8% glycated Hb (HbA1C)
  3. Malabsorption syndrome
  4. Known brain metastases not radiographically stable for ≥3 months or leptomeningeal disease
  5. History of myocardial infarction (MI) or NYHA Class II-IV congestive heart failure within 6 months of the administration of the first dose of ARQ 092 (MI occurring >6 months of the first dose of ARQ 092 will be permitted); Grade 2 or worse conduction defect (eg right or left bundle branch block); left ventricular ejection fraction (LVEF) < 50% assessed by echocardiogram/MUGA scan
  6. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of the first dose of ARQ 092 (within 2 weeks for orally administered drugs)
  7. Major surgery within four weeks of the first dose of ARQ 092
  8. Previous treatment with AKT inhibitors
  9. Concurrent severe uncontrolled illness not related to cancer
  10. Ongoing or active known infection, including human immunodeficiency virus (HIV) infection or bleeding
  11. Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements.
  12. Blood transfusion within 5 days prior to blood draw being used to confirm eligibility
  13. Pregnant or breastfeeding
  14. Previous other malignancy within 2 years prior to the first dose of ARQ 092, with the exception of carcinoma in-situ of the cervix, basal cell carcinoma and superficial bladder tumors curatively treated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473095

Contacts
Contact: ArQule, Inc. 781-994-0300 ClinicalTrials@arqule.com

Locations
United States, Alabama
Not yet recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Recruiting
Scottsdale, Arizona, United States, 85258
United States, Florida
Not yet recruiting
Miami, Florida, United States, 33136
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30341
United States, Indiana
Recruiting
Lafayette, Indiana, United States, 47905
United States, Texas
Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ArQule
  More Information

No publications provided

Responsible Party: ArQule
ClinicalTrials.gov Identifier: NCT01473095     History of Changes
Other Study ID Numbers: ARQ 092-101
Study First Received: November 10, 2011
Last Updated: November 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ArQule:
AKT

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014