Approval Probability
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Also known as ABT-869
linifanib · 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Linifanib is an investigational small molecule being studied in oncology for advanced solid tumors and non-small cell lung cancer. It has been evaluated in Phase 1 clinical trials, including an extension study in patients with advanced or metastatic solid tumors and a combination study in Japanese patients with NSCLC.
Linifanib targets FLT3, FLT1, FLT4, KDR, CSF1R, and PDGFRB. It is a small molecule inhibitor of these receptor tyrosine kinases, which are involved in angiogenesis and tumor cell signaling. By inhibiting these targets, linifanib may interfere with processes that support tumor growth and survival.
Linifanib is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating linifanib in advanced solid tumors and non-small cell lung cancer.
Linifanib is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 trials have been completed, and no active trials are currently listed for linifanib.
Linifanib has been studied in two completed Phase 1 trials: NCT01413893, an extension study in subjects with advanced or metastatic solid tumors that enrolled 35 patients, and NCT01225302, which evaluated linifanib in combination with carboplatin and paclitaxel in Japanese subjects with non-small cell lung cancer and enrolled 12 patients.