Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-869 · 7 trials · 9 indications
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 | - |
| Single arm | EXPERIMENTAL | One oral dose daily |
| 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) |
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 being studied in oncology. It has been evaluated in clinical trials for advanced renal cell carcinoma, advanced non-small cell lung cancer (NSCLC), advanced or metastatic NSCLC, advanced solid tumors, advanced colorectal cancer, and metastatic breast cancer. It is not approved and remains in clinical development.
ABT-869 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug has completed Phase 2 trials in oncology indications.
ABT-869 has completed Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. Its development status is based on completed trials in advanced renal cell carcinoma and non-small cell lung cancer.
ABT-869 has been studied in several completed trials. NCT00486538 evaluated it in advanced renal cell carcinoma after sunitinib treatment. NCT00517790 studied it in advanced NSCLC. NCT00716534 tested it with carboplatin and paclitaxel in advanced or metastatic NSCLC. NCT00733187 examined food effects and diurnal variation in advanced solid tumors.
ABT-869 is also known by the name linifanib. The drug has been referred to by both names in clinical research contexts. It is an investigational small molecule oncology agent developed by AbbVie.