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A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01506934
First received: October 11, 2011
Last updated: August 24, 2012
Last verified: August 2012

October 11, 2011
August 24, 2012
October 2011
December 2011   (final data collection date for primary outcome measure)
Calculate the Cmax and Tmax of participating subjects [ Time Frame: PK parameters will be measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose in each study period. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01506934 on ClinicalTrials.gov Archive Site
  • Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: All adverse events occuring from Day 1 of Period 1 through the Final Visit will be reported. ] [ Designated as safety issue: Yes ]
    The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis on Days 1 through 7 of Periods 1, 2 and 3. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the case report forms. All adverse events will be followed to a satisfactory clinical resolution.
  • Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. [ Time Frame: Physical exam at Screening, Day 1 of Periods 1, 2 and 3 and Day 5, Period 2 (FE portion), Day 5, Period 3 (BA Portion)/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits. ] [ Designated as safety issue: Yes ]
  • Safety: Clinical Lab Tests will be performed for each participant as a safety measure. [ Time Frame: Screening, Day 1, Periods 1 and 2, Day 5, Period 2 (FE portion), Day 5, Period 3 (BA portion)/Final Visit and 30 day safety follow-up. ] [ Designated as safety issue: Yes ]
    Chemistry, hematology, urinalysis lab tests
Same as current
Not Provided
Not Provided
 
A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1, Open Label, Randomized, Adaptive, Cross-Over Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib.

This study is designed to evaluate the bioavailability of linifanib from two formulations and the effect of food on the pharmacokinetics of the linifanib formulation intended for commercialization. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Advanced or Metastatic Solid Tumors
Drug: linifanib

Single Dose on Day 1 of Periods 1, 2 and 3 (Bioavailability Portion)

Single Dose on Day 1 of Periods 1 and 2 (Food Effect Portion)

Other Name: ABT-869
Experimental: linifanib
Single Doses
Intervention: Drug: linifanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
January 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Age is greater than or equal to 18 years.
  2. Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC).
  3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  4. Subject must have adequate bone marrow, renal and hepatic function as follows:

    • Bone Marrow: Absolute neutrophil count (ANC) >= 1,500/mm3 (1.5 X 109/L); Platelets >= 75,000/mm3 (75 X 109/L); Hemoglobin >= 9.0 g/dL (1.4 mmol/L)
    • Renal function: serum creatinine <= 2.0 mg/dL (0.81 mmol/L);
    • Hepatic function: AST and ALT <= 1.5 X ULN unless liver metastases are present, then AST and ALT <= 5.0 X ULN; bilirubin <= 1.5 mg/dL (0.026 mmol/L)
  5. Subject must have Partial Thromboplastin Time (PTT) </= 1.5 x Upper Limit of Normal ( ULN) and International Normalized Ratio (INR) </= 1.5.

Exclusion Criteria

  1. Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation therapy or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. In addition subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
  2. Subject has undergone major surgery within 21 days of Period 1, Study Day 1.
  3. Subject has untreated brain or meningeal metastases. Subjects with treated brain metastases that are radiographically or clinically stable (for at least 4 weeks after therapy) and who have no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to Study Day 1, Period 1).
  4. Current enrollment in another clinical trial.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01506934
M12-468
No
Abbott
Abbott
Not Provided
Not Provided
Abbott
August 2012

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