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.
Verified August 2013 by ArQule
Sponsor:
Information provided by (Responsible Party):
ArQule
ClinicalTrials.gov Identifier:
NCT01473095
First received: November 10, 2011
Last updated: August 21, 2013
Last verified: August 2013

November 10, 2011
August 21, 2013
November 2011
March 2015   (final data collection date for primary outcome measure)
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 ]
Assess the safety and tolerability of ARQ 092 in subjects with advanced solid tumors 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 ]
Complete list of historical versions of study NCT01473095 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma
A Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2015
March 2015   (final data collection date for primary outcome measure)

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)
  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.
Both
18 Years and older
No
Contact: ArQule, Inc. 781-994-0300 ClinicalTrials@arqule.com
United States
 
NCT01473095
ARQ 092-101
No
ArQule
ArQule
Not Provided
Not Provided
ArQule
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP