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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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ArQule Identifier:
First received: November 10, 2011
Last updated: March 17, 2017
Last verified: March 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]

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 ]
  • Assess pharmacodynamic activity [ Time Frame: During the first 29 days of treatment ]
  • 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 ]
  • Determine recommended Phase 2 dose [ Time Frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks ]

Estimated Enrollment: 125
Study Start Date: November 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01473095

United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Florida
Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30322
Atlanta, Georgia, United States, 30341
United States, Indiana
Lafayette, Indiana, United States, 47905
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
  More Information

Responsible Party: ArQule Identifier: NCT01473095     History of Changes
Other Study ID Numbers: ARQ 092-101
Study First Received: November 10, 2011
Last Updated: March 17, 2017

Keywords provided by ArQule:
ARQ 092
Targeted therapy
Molecular therapy
Phase 1
Phase I
Endometrial cancer
AKT pathway
AKT signaling
AKT inhibitor
AKT pan inhibitor
AKT1 mutation
AKT1-E17K mutation
AKT 2 inhibitor
AKT 3 inhibitor
AKT 3 amplification
PI3K AKT mTOR signalling pathway
mTOR inhibitor
PI3K inhibitor
Clinical oncology
PIK3CA H1047R mutation

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on May 22, 2017