Recent Updates
Recently added Catalysts

ECF

Phase 2

Esophageal Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 29, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment245

FDA Designations

No designations recorded

Clinical trial landscape

ECF · 1 trial · 1 indication

Phase 2 1
NCT00381706Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction CancerEsophageal Cancer
COMPLETED245 Analytics
PHASE2COMPLETED
Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Esophageal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma
Up to 2 years post-treatment

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy.

Secondary Endpoints

Tumor Response Rate (Complete and Partial) in Patients With Squamous Cell Carcinoma
Up to 2 years post-treatment
Overall Survival in Patients With Adenocarcinoma
Up to 2 years post-treatment
Progression-free Survival in Patients With Adenocarcinoma
Up to 2 years post-treatment
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A (ECF + cetuximab)EXPERIMENTALPatients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
Arm B (IC + cetuximab)EXPERIMENTALPatients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
ARM C (FOLFOX + cetuximab)EXPERIMENTALPatients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
cetuximabBIOLOGICALgiven IV
ECFDRUGepirubicin and 5-fluorouracil given IV
ICDRUGcisplatin and irinotecan given IV
FOLFOXDRUGoxaliplatin , leucovorin and 5-fluorouracil IV
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites227

1. Metastatic disease of the esophagus or gastroesophageal junction 1. Histologic, cytologic or radiologic documentation of metastatic squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction. Radiologic, endoscopic, histologic or cytologic evidence of locally recu...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Esophageal Cancer 107 trials

Unlock Competitive Intelligence

Frequently asked questions about ECF

What is ECF used for in esophageal cancer?

ECF is an investigational small molecule being studied for the treatment of esophageal cancer. It is being evaluated in combination with chemotherapy and cetuximab for patients with metastatic esophageal cancer or gastroesophageal junction cancer. The drug is currently in Phase 2 clinical development.

Who is developing ECF?

ECF is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with esophageal cancer.

What phase is ECF in?

ECF is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial for the treatment of esophageal cancer.

What clinical trials is ECF in?

ECF has been studied in one completed clinical trial, identified as NCT00381706. This Phase 2 trial enrolled 245 patients with metastatic esophageal cancer or gastroesophageal junction cancer. The trial evaluated combination chemotherapy and cetuximab with ECF in the United States.

Is ECF the same as other drugs?

ECF is a distinct drug candidate being developed by Bristol-Myers Squibb. It is being studied as part of a combination regimen that includes chemotherapy and cetuximab for the treatment of esophageal cancer. No alternative names for ECF have been disclosed.