Full Text View
Tabular View
No Study Results Posted
Related Studies
RDEA119 and Sorafenib Combination Dose Escalation Study
This study is currently recruiting participants.
Verified by Ardea Biosciences, Inc., August 2009
First Received: November 4, 2008   Last Updated: September 22, 2009   History of Changes
Sponsor: Ardea Biosciences, Inc.
Information provided by: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00785226
  Purpose

Phase 1/2 dose escalation study to investigate the combination of RDEA119 and sorafenib in advanced cancer patients


Condition Intervention Phase
Advanced Cancer
Drug: RDEA119 and Sorafenib
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety Study
Official Title: A Phase 1/2 Study of the Combination of RDEA119 and Sorafenib in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Ardea Biosciences, Inc.:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of escalating continuous oral dosing of RDEA119 in combination with sorafenib in advanced cancer patients. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • •Determine PK and PD of drugs in combination, describe responses and correlate with toxicity, and screen select tumors in Phase 2 portion. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: October 2008
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
RDEA119 with Sorafenib: Experimental Drug: RDEA119 and Sorafenib
Total daily doses of RDEA119 from 10 mg/day to 40 mg/day and sorafenib from 400 mg/day to 800 mg/day.

  Eligibility

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

Inclusion Criteria:

  • ECOG performance status of 0-1.
  • Histological or cytological confirmed diagnosis of a solid tumor which is unresectable and locally advanced, or metastatic in which no proven effective therapy exists or for patients who are intolerant to such therapy.
  • Patients > 18 years of age.
  • Life expectancy of > 3 months
  • Evidence of measurable disease by RECIST criteria.
  • No clinically significant abnormalities in Amylase and Lipase, Hemoglobin, ANC, Platelet count, Total Bilirubin, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT), PTT, prothrombin time (PT), and INR or Creatinine.
  • Patients receiving anti-coagulation treatment with an agent such as warfarin or low molecular weight heparin may be allowed to participate, but must not have active bleeding or a pathologic condition that carries a high risk of bleeding.
  • Patients must not be pregnant or breast-feeding. Men and women of reproductive potential may not participate in this study unless they have agreed to use an effective contraceptive method while on study.
  • Patients must be within normal range cardiac function as measured by echocardiogram or multiple-gated acquisition (MUGA) scan.

Exclusion Criteria:

  • Previous treatment with sorafenib that required a dose reduction due to toxicity or previous treatment with RDEA119.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Swallowing dysfunction and/or malabsorption syndrome
  • Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents < 4 weeks from the first dose of study drug.
  • Cardiac disease or Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Known HIV infection or other uncontrolled active infections.
  • Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.
  • The use of inhibitors or inducers of CYP3A4 and CYP2C19 enzymes.
  • Patients with abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, or small bowel resection, any of which is within 6 months of study entry.
  • Patients with abdominal radiation resulting in chronic diarrhea.
  • Patients with documented central nervous system (CNS) metastasis who are not off steroids and other CNS therapies.
  • Other serious medical or psychiatric illness that would not permit the patient to be managed according to the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785226

Contacts
Contact: Beth Sheedy 858.652.6604

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Amy Kramer     215-662-7013     amy.kramer@uphs.upenn.edu    
Principal Investigator: Peter O'Dwyer, MD            
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: Vijay Hingorani, MD, PhD, MBA Ardea Biosciences, Inc.
  More Information

No publications provided

Responsible Party: Ardea Biosciences ( Kimberly Manhard, Sr. VP Regulatory Affairs and Operations )
Study ID Numbers: RDEA119-103
Study First Received: November 4, 2008
Last Updated: September 22, 2009
ClinicalTrials.gov Identifier: NCT00785226     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Sorafenib
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009