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Vectibix

Phase 1

Colorectal Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Oct 31, 2014

Target and mechanism

ModalitySmall molecule

Also known as Vectibix® (panitumumab)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Vectibix · 1 trial · 1 indication

Phase 1 1
NCT00879385KRAS Wild-type Metastatic Colorectal Cancer TrialColorectal Cancer
COMPLETED21 Analytics
PHASE1COMPLETED
KRAS Wild-type Metastatic Colorectal Cancer Trial
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate safety & feasibility of sequential use of a DNA methyltransferase (DNMT) inhibitor (decitabine) with targeted biological agent against EGFR (panitumumab) for KRAS wild type tumors in second or third line treatment of colorectal cancer.
2 years

Secondary Endpoints

To examine re-expression or a reduction in promoter methylation in genes involved in tumor suppressor pathways known to be important in colorectal cancer (CRC) or involved in EGFR signaling pathway.
2 years
Evaluate overall response (OR = CR +PR) according to RECIST criteria at 2, 4, and 6 cycles. Progression free survival, measured as the first evidence of tumor growth from the start of treatment will also be assessed.
2 years
Measure CEA levels at the beginning of each cycle to examine if they correlate with treatment response or disease progression.
2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
All patientsEXPERIMENTALAll participants enrolled.

Interventions

NameTypeDescription
Dacogen™ (decitabine)DRUGDacogen™ (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)DRUGVectibix® (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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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/...

Countries:United States
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