Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as linifanib
ABT-869 · 10 trials · 11 indications
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.
MUGA
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.
Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.
Blood samples for the pharmacokinetics of linifanib will be collected for each subject and each regimen (fasting, fed, AM and PM dosings).
Triplicate ECG will be performed at designated timepoints.
Only treatment emergent AEs will be included. Toxicity grade, relationship to study drug and AEs leading to discontinuation will be evaluated.
Blood chemistry and hematology will be analyzed based on the regimen and dosing and overall. 24 hr ABPM will be analyzed by regimen and dosing time and overall.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | Open-label to Bevacizumab plus mFOLFOX6 |
| B | ACTIVE_COMPARATOR | Open-label to High-dose ABT-869 arm plus mFOLFOX6 |
| C | ACTIVE_COMPARATOR | Open-label to low-dose ABT-869 arm plus mFOLFOX6 |
| ABT-869 | EXPERIMENTAL | - |
| ABT-869 0.25 mg/kg | EXPERIMENTAL | Approximately half of the subjects were randomized to receive the high dose |
| ABT-869 0.10 mg/kg | EXPERIMENTAL | Approximately half of the subjects were randomized to receive the Low Dose |
| Single arm | EXPERIMENTAL | One oral dose daily |
| linifanib | EXPERIMENTAL | - |
| Arm A | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| Group 1 | EXPERIMENTAL | Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days |
| Group 2 | EXPERIMENTAL | Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1 |
| Group 3 | EXPERIMENTAL | Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2 |
| Group 4 | EXPERIMENTAL | Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3 |
| Name | Type | Description |
|---|---|---|
| ABT-869 | DRUG | 12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle |
| bevacizumab | DRUG | 10 mg/kg QD, IV on Day 1 of each 14-day cycle |
| oxaliplatin | DRUG | 85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle |
| folinic acid | DRUG | 400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle |
| fluorouracil | DRUG | 400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours |
| paclitaxel | DRUG | 90 mg/m2 IV infusion over 1 hour, weekly every 3 out of 4 weeks |
| Placebo for ABT-869 | DRUG | 0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle |
| Carboplatin | DRUG | Carboplatin (AUC 6 mg/mL/min) |
| ABT-869 .25 mg/kg | DRUG | Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight. |
| ABT-869 0.10 mg/kg | DRUG | Subjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight. |
| linifanib | DRUG | QD daily |
Inclusion Criteria: Subject must be \>/= 18 years of age. Subject (male or female) must be diagnosed with adenocarcinoma of the colon or rectum. Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent. Subject must have rece...
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ABT-869 is an investigational small molecule oncology drug developed by AbbVie Inc. (ticker ABBV). It has been studied in Phase 2 clinical trials across several advanced cancers, including colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, non-small cell lung cancer, breast cancer, and advanced solid tumors. It is not described as approved and remains in clinical development.
ABT-869 was studied in advanced colorectal cancer in a Phase 2 trial combining it with mFOLFOX6 chemotherapy and comparing that regimen with bevacizumab plus mFOLFOX6. That trial, NCT00707889, enrolled 159 patients and has been completed. ABT-869 is investigational and is not an approved treatment for colorectal cancer.
ABT-869 is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the clinical development program for ABT-869 across the advanced solid tumor and cancer indications studied in its trials.
ABT-869 is in Phase 2 development. Its clinical program includes Phase 1 and Phase 2 studies, and the Phase 2 trials have been completed. The drug is investigational and is not described as FDA approved for any indication.
ABT-869 has been evaluated in completed trials including NCT00733187, a Phase 1 pharmacokinetic study of food effects and diurnal variation in advanced solid tumors; NCT00718380, a Phase 1 solid tumor study; NCT00716534, a Phase 2 study with carboplatin and paclitaxel in advanced or metastatic non-small cell lung cancer; and NCT00707889, a Phase 2 colorectal cancer study.