Phase 1
Completed N=98
Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor
Source: ClinicalTrials.gov NCT00454649 ↗Enrolled (actual)
98
Serious AEs
55.1%
Results posted
Mar 2012
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy — 5; 5; 5; 5 mg BID
Summary
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy |
5; 5; 5; 5; NA; 5 | — |
| SECONDARY Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736) |
61.58; 242.41; 475.18; 154.43; 780.99; 365.95 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736) |
5.97; 23.36; 42.58; 44.58; 67.96; 37.51 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Axitinib (AG-013736) |
— | — |
| SECONDARY Apparent Oral Clearance (CL/F) for Axitinib (AG-013736) |
49.39; 40.72; 29.73; 65.69; 14.35; 26.64 | — |
| SECONDARY Plasma Decay Half Life (t1/2) for Axitinib (AG-013736) |
2.75; 2.90; 2.80; 1.45; 4.07; 3.85 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel |
5683.55; 19959.91 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Paclitaxel |
3698.33; 6105.00 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Paclitaxel |
— | — |
| SECONDARY Plasma Clearance (CL) for Paclitaxel |
30.48; 21.61 | — |
| SECONDARY Plasma Decay Half Life (t1/2) for Paclitaxel |
12.51; 8.36 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel |
3478.49 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Docetaxel |
3130.00 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Docetaxel |
— | — |
| SECONDARY Plasma Clearance (CL) for Docetaxel |
42.96 | — |
| SECONDARY Plasma Decay Half Life (t1/2) for Docetaxel |
11.49 | — |
| SECONDARY Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine |
20534.52; 22163.88 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Capecitabine |
10808.00; 10588.38 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Capecitabine |
— | — |
| SECONDARY Apparent Oral Clearance (CL/F) for Capecitabine |
209.05; 314.12 | — |
| SECONDARY Plasma Decay Half Life (t1/2) for Capecitabine |
0.85; 1.44 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine |
10991.16 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Gemcitabine |
20635.29 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Gemcitabine |
— | — |
| SECONDARY Plasma Clearance (CL) for Gemcitabine |
224.36 | — |
| SECONDARY Plasma Decay Half Life (t1/2) for Gemcitabine |
0.29 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin |
55580.26 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Carboplatin |
23383.33 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Carboplatin |
— | — |
| SECONDARY Plasma Clearance (CL) for Carboplatin |
12.57 | — |
| SECONDARY Plasma Decay Half Life (t1/2) for Carboplatin |
2.62 | — |
| SECONDARY Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin |
2932.43; 2703.92 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Cisplatin |
1680.54; 1176.00 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Cisplatin |
— | — |
| SECONDARY Plasma Clearance (CL) for Cisplatin |
46.31; 46.80 | — |
| SECONDARY Plasma Decay Half Life (t1/2) for Cisplatin |
2.61; 3.91 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed |
133032.97 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) for Pemetrexed |
83925.00 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) for Pemetrexed |
— | — |
| SECONDARY Plasma Clearance (CL) for Pemetrexed |
7.26 | — |
| SECONDARY Plasma Decay Half Life (t1/2) for Pemetrexed |
2.77 | — |
| SECONDARY Percentage of Participants With Objective Response |
100.0; 0; 35.0; 66.7; 50.0; 11.1 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced solid tumors suitable for treatment with Taxanes, with or without carboplatin, or treatment with Capecitabine, Gemcitabine/Cisplatin. or Pemetrexed/Cisplatin
Exclusion Criteria
- Tumors abutting or providing support for blood vessels
- Any significant gastrointestinal abnormalities or active bleeding.
Data sourced from ClinicalTrials.gov (NCT00454649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.