linifanib

Mark D. McKee, MD

A pharmacokinetic study to compare 2 clinical formulations of linifanib.

This study is designed to evaluate the bioavailability of linifanib from 2 formulations. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.

A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors

Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.

The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study.

Complete physical exam, including body weight, will be done at Screening. A symptom-directed physical exam, including bodyweight, will be done at Day 1, Periods 1 and 2, Day 5, Period 2/Final Visit and 30 day safety follow-up.

Chemistry, hematology, urinalysis lab tests

Abbott

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Linifanib

Susumu Matsuki, BS

The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment.

A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment

Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.

AbbVie

An extension study of linifanib in subjects with advanced or metastatic solid tumors.

This study is designed to evaluate the safety of linifanib in subjects with advanced or metastatic solid tumors.

An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors

An Extension Study of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.

Physical exam, blood pressure, pulse, body temperature will be measured and recorded on the case report forms.

Chemistry, hematology, urinalysis lab tests will be measured and recorded on the case report forms. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution.

There are no secondary outcome measures specified for this study.

Symptoms and General Pathology

Digestive System Diseases

Recurrence

Rectal Neoplasms

Colonic Neoplasms

Disease Attributes

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Amino Acids

Tyrosine Kinase Inhibitors

Enzyme Inhibitors

Protein Kinase Inhibitors

Tyrosine

Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Jordan Berlin, MD

This phase II trial studies how well Linifanib works in treating patients with advanced, refractory colorectal cancer expressing k-Ras mutations. Linifanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To achieve an overall response rate of 15% or more.

SECONDARY OBJECTIVES:

I. Determine progression free survival. II. Determine overall survival. III. Evaluate toxicity profile of ABT 869 (linifanib) in this patient population.

OUTLINE:

Patients receive Linifanib orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years, and then every 6 months for 3 years.

Linifanib in Treating Patients With Advanced, Refractory Colorectal Cancer

An Investigator Initiated, Phase II Study of Linifanib in Patients With Advanced, Refractory Colorectal Cancer Expressing Mutated kRas

Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Defined as the CR + PR recorded from the start of the treatment until disease progression/recurrence, the exact two-sided 95% confidence intervals will be reported.

Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring. Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.

Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring.

Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1= mild; grade 2 = moderate; grade 3 = severe; grade 4 = life-threatening; grade 5 = death

Assessed: days 1 \&15 of cycle 1; day 1 of each subsequent 28-day cycle; at 30-day follow-up for two years

Vanderbilt-Ingram Cancer Center

Professor of Medicine; Clinical Director, GI Oncology Program; Director, Phase I Program; Medical Director, Clinical Trials Shared Resources; Medical Oncologist

Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

linifanib: Given PO

Treatment (Enzyme Inhibitor)

Age 20-29

Age 40-49

Age 50-59

Age 60-69

Age 70-79

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Dr. Jordan Berlin

All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.

Overall Response Rate (Complete Response + Partial Response) With a Target of at Least 15%

All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date.

Progression-free Survival

Overall Survival

worst grade toxicity 1

worst grade toxicity 2

worst grade toxicity 3

worst grade toxicity 4

worst grade toxicity 5

Total number of patients reported with any toxicity

Number of Patients With Each Worst-Grade Toxicity

ABT-869/Linifanib will be administered orally on a daily basis at 17.5 mg/day (fixed dose). The drug is provided in tablets of 2.5 mg or 10 mg tablets.This course of treatment repeats every 28 days until disease progression, intolerability, investigator decision or patient withdrawal of consent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.	NCT01381341	Advanced Solid ...	linifanib	18 Years -	Abbott
A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)	NCT01225302	Non-Small Cell ...	Linifanib Linifanib Carboplatin Paclitaxel	20 Years - 99 Years	AbbVie
An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors	NCT01413893	Advanced Solid ...	linifanib	18 Years - 99 Years	AbbVie
An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors	NCT01413893	Advanced Solid ...	linifanib	18 Years - 99 Years	AbbVie
Linifanib in Treating Patients With Advanced, Refractory Colorectal Cancer	NCT01365910	Recurrent Colon... Recurrent Recta... Stage IVA Colon... Stage IVA Recta... Stage IVB Colon... Stage IVB Recta...	linifanib	18 Years -	Vanderbilt-Ingram Cancer Center

Spots Global Cancer Trial Database for linifanib

Every month we try and update this database with for linifanib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for linifanib

Every month we try and update this database with for linifanib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for linifanib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.