Phase 2
Completed N=61
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00460603 ↗Enrolled (actual)
61
Serious AEs
44.0%
Results posted
Jun 2013
Primary outcomePrimary: Percentage of Participants With Objective Response: Phase 2 — 28.6; 48.8; 39.0 Percentage of participants — p=0.9726
Summary
To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response: Phase 2 |
28.6; 48.8; 39.0 | 0.9726 |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1 |
119.02; 106.76; 97.05; 95.70; 143.68; 117.47 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1 |
190.51; 113.20; 205.41; 224.46; 168.07; 178.46 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1 |
35.57; 27.14; 24.23; 27.51; 42.48; 32.62 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1 |
— | — |
| SECONDARY Apparent Oral Clearance (CL/F) For Axitinib: Phase 1 |
30.01; 47.10; 28.49; 30.08; 33.33; 28.90 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1 |
3.26; 2.23; 3.47; 6.12; 3.09; 1.73 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1 |
4814.87; 4308.71; 5231.71; 5303.66 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1 |
5955.70; 5137.31; 6744.06; 6430.67 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1 |
278.81; 265.05; 318.99; 374.03 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1 |
— | — |
| SECONDARY Clearance (CL) For Oxaliplatin: Phase 1 |
27.51; 30.74; 24.29; 24.56 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1 |
20.63; 18.38; 23.30; 19.86 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1 |
39212.03; 40955.29; 52164.28; 45087.71; 36533.84; 95123.13 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1 |
36314.14; 41460.50; 52430.15; 38983.80; 36776.79; 96632.41 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1 |
16160.85; 34436.94; 19622.74; 16249.77; 39730.46; 34180.87 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1 |
— | — |
| SECONDARY Clearance (CL) For 5-Fluorouracil: Phase 1 |
147.43; 128.28; 99.36; 137.34; 144.62; 53.92 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1 |
0.26; 0.19; 0.39; 0.25; 0.14; 0.24 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1 |
12081.58; 11496.32 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1 |
13055.88; 12459.89 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1 |
1910.25; 1788.69 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1 |
— | — |
| SECONDARY Clearance (CL) For Irinotecan: Phase 1 |
26.09; 27.34 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1 |
6.45; 6.75 | — |
| SECONDARY Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1 |
3394758.83; 3554899.52 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1 |
4987528.96; 5114888.84 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1 |
26460.05; 26850.12 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1 |
— | — |
| SECONDARY Clearance (CL) For Bevacizumab: Phase 1 |
0.01; 0.02 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1 |
205.97; 210.22 | — |
| SECONDARY Duration of Response (DR): Phase 2 |
434.0; NA; 343.0 | — |
| SECONDARY Progression-Free Survival (PFS): Phase 2 |
336; 485; 381 | 0.5699 |
| SECONDARY Time to Treatment Failure (TTF): Phase 2 |
187.0; 241.0; 238.0 | 0.8884 |
| SECONDARY Overall Survival (OS): Phase 2 |
552.0; 659.0; 601.0 | 0.6904 |
| SECONDARY Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2 |
1.62; 2.20; 2.18; 0.63; 0.04; 0.80 | — |
Eligibility Criteria
Inclusion Criteria
- (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment
- (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
- Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was > 12 months prior to enrollment,
- Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.
Exclusion Criteria
- Prior system therapy for advanced CRC (Ph 2 portion only)
- Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
- Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
- Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed > 2 weeks of enrollment and be fully recovered from any procedure.
Data sourced from ClinicalTrials.gov (NCT00460603). 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.