Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00879385 | KRAS Wild-type Metastatic Colorectal Cancer Trial | PHASE1 | COMPLETED | 21 | — | — | Dec 1, 2009 | Jan 1, 2013 | Oct 31, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| All patients | EXPERIMENTAL | All participants enrolled. |
| Name | Type | Description |
|---|---|---|
| Dacogen™ (decitabine) | DRUG | Dacogen™ (decitabine) is a FDA approved drug (NDA - 021790) for the treatment of myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia). Decitabine will be given on this study at 45 mg/m2 IV over 2 hrs |
| Vectibix® (panitumumab) | DRUG | Vectibix® (panitumumab) is a FDA approved drug (BLA-125147) indicated as a single agent for the treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival. DRUG DESCRIPTION Vectibix® (panitumumab) is a recombinant, human IgG2 kappa monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). Panitumumab has an approximate molecular weight of 147 kDa. Panitumumab is produced in genetically engineered mammalian (Chinese Hamster Ovary) cells. Panitumumab will be given on this study at 6 mg/kg, IV over 1 hr |
Inclusion Criteria: 1. At least third line stage IV metastatic colorectal cancer or metastatic colorectal cancer patients intolerant to second line therapy. 2. Tumor is KRAS wild-type. 3. ECOG performance status of 0-1 4. Age (≥)18 5. Adequate bone marrow function (ANC \>1500/mm3, hemoglobin \>9 g/...