Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Axitinib
AG-013736 · 17 trials · 16 indications
Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]).
MTD is defined as the dose level at which "no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD)." DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| AG-013736/Cisplatin/Gemcitabine | EXPERIMENTAL | - |
| C | EXPERIMENTAL | AG-013736 (axitinib) |
| D | ACTIVE_COMPARATOR | bevacizumab (avastin) |
| AG-013736 | EXPERIMENTAL | - |
| AG-013736 (axitinib) | EXPERIMENTAL | AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity |
| Gemcitabine | ACTIVE_COMPARATOR | - |
| Axitinib [AG-013736] plus gemcitabine | EXPERIMENTAL | - |
| Axitinib [AG-013736] | EXPERIMENTAL | - |
| Single arm study | EXPERIMENTAL | - |
| Sequence 1 (BABA) | EXPERIMENTAL | Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: B -\> A -\> B -\> A |
| Sequence 2 (ABAB) | EXPERIMENTAL | Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: A -\> B-\> A -\> B |
| Cohort 1 | EXPERIMENTAL | - |
| Sequence 1 (ABC) | OTHER | The following treatments will be administered in the following order A -\> B-\> C 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal. |
| Sequence 2 (ACB) | OTHER | The following treatments will be administered in the following order A -\> C -\> B 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal. |
| Sequence 3 (BCA) | OTHER | The following treatments will be administered in the following order B -\> C -\> A 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal. |
| Sequence 4 (BAC) | OTHER | The following treatments will be administered in the following order B -\> A -\> C 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal. |
| Sequence 5 (CAB) | OTHER | The following treatments will be administered in the following order C -\> A -\> B 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal. |
| Sequence 6 (CBA) | OTHER | The following treatments will be administered in the following order C -\> B -\> A 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal. |
| Hepatic Function - Mild Impairment | EXPERIMENTAL | Subjects with mild hepatic impairment (Child Pugh class A, score 5-6) |
| Hepatic Function - Moderate Impairment | EXPERIMENTAL | Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9) |
| Hepatic Function - Normal | EXPERIMENTAL | Group 1 1\) subjects with normal hepatic function |
| Docetaxel + Placebo | OTHER | Docetaxel + Placebo |
| Docetaxel + AG-013736 | EXPERIMENTAL | Docetaxel + AG-013736 |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Cohort 6 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AG-013736 | DRUG | oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression. |
| Gemcitabine | DRUG | intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression. |
| placebo | DRUG | placebo |
| cisplatin | DRUG | 1mg/ml solution or as lyophilized powder, to be administered as 80 mg/m\^2 IV infusion on Day 1 of 21-day cycle. For a maximum of 6 cycles |
| Bevacizumab | DRUG | Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks. |
| Carboplatin | DRUG | Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks. |
| Paclitaxel | DRUG | Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks |
| AG-013736 (axitinib) | DRUG | AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID- |
| Bevacizumab (avastin) | DRUG | Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent. |
| FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) | DRUG | Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \[IV\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent. |
| FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) | DRUG | Oxaliplatin (85 mg/m²) intravenous infusion \[IV\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent. |
| AG013736 | DRUG | AG013736, tablets 5 mg BID daily until tumor progression or toxicity |
| AG-103736 | DRUG | single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B) |
| Docetaxel | DRUG | Standard of care drug administration |
Inclusion Criteria: * Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection. * Adequate renal, hepatic and bone marrow function. * Performance status 0 or 1. Exclusion Criteria: * Prior treatment with any systemic ...
AG-013736, also known as axitinib, is an investigational small molecule being studied for use in oncology. Clinical trials have evaluated it in metastatic renal cell cancer, squamous non-small-cell lung cancer, advanced solid tumors, and hepatic insufficiency. It is being developed by Pfizer, Inc. and is currently in Phase 2 clinical development.
AG-013736 is a kinase inhibitor, belonging to the -tinib class of targeted therapies. As a small molecule kinase inhibitor, it works by blocking specific enzymes involved in cancer cell growth and proliferation. The drug is being investigated for its activity against various tumor types, including renal cell carcinoma and non-small-cell lung cancer.
AG-013736 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is also known by the name axitinib. It is currently in Phase 2 clinical development for oncology indications.
AG-013736 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Completed clinical trials include Phase 1 and Phase 2 studies evaluating the drug in patients with renal cell cancer, non-small-cell lung cancer, advanced solid tumors, and hepatic insufficiency.
AG-013736 has been studied in several completed clinical trials. NCT00569946 evaluated axitinib as second-line treatment in metastatic renal cell cancer. NCT00735904 tested AG-013736 combined with cisplatin and gemcitabine in squamous non-small-cell lung cancer. NCT01469052 was a first-in-human Phase 1 study in advanced solid tumors, and NCT00692341 assessed hepatic impairment effects.
Yes, AG-013736 is the same drug as axitinib. Axitinib is the alternative name for AG-013736, and both names refer to the same investigational compound being developed by Pfizer, Inc. The drug is a small molecule kinase inhibitor currently in Phase 2 clinical trials for oncology indications.