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A Phase II Randomized Clinical Trial of Panitumumab plus Gemcitabine and Oxaliplatin (GEMOX) versus GEMOX alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma - Vecti-BIL

A Phase II Randomized Clinical Trial of Panitumumab plus Gemcitabine and Oxaliplatin (GEMOX) versus GEMOX alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma - Vecti-BIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017428-17-IT
Enrollment
Unknown
Registered
2010-02-19
Start date
2010-05-31
Completion date
Unknown
Last updated
2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced intrahepatic colangiocarcinoma and extrahepatic biliary adenocarcinoma including gallbladder MedDRA version: 9.1 Level: LLT Classification code 10008594 MedDRA version: 9.1 Level: LLT Classification code 10025943 MedDRA version: 9.1 Level: LLT Classification code 10061239 MedDRA version: 9.1 Level: LLT Classification code 10022789

Interventions

Trade Name: VECTIBIX Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PANITUMUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentrat

Sponsors

AZIENDA OSPEDALIERA ORDINE MAURIZIANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Histologically or cytologically documented surgically unresectable or metastatic biliary tract adenocarcinoma (KRAS wild-type); ? Documented KRAS status either on primary tumor or metastasis. ? ECOG PS of 0, 1 or 2 ? Extimated life expectancy of at least 3 months. ? Adequate bone marrow, hepatic, and renal function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? Any previous chemotherapy or target therapy. ? Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. ? Coexisting malignancies, except for basal or squamous cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type).;Secondary Objective: To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy.;Primary end point(s): Progression-free survival (PFS), defined as the time from randomization to evidence of progression, death, or last radiographic assessment in absence of a PFS event.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026