Clinical trial · Interventional
Study of IMC-11F8 in Participants With Colorectal Cancer
Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer
NCT00835185CI-TRIAL-00020720completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Folinic acid (FA) | Drug | — | UNRESOLVED |
| IMC-11F8 (necitumumab) | Biological | Necitumumab | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMC-11F8 (necitumumab) /mFOLFOX-6 regimen
- description
- Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)
- interventionNames
- Biological: IMC-11F8 (necitumumab)
- Drug: Oxaliplatin
- Drug: Folinic acid (FA)
- Drug: 5-FU
Primary outcomes (1)
- measure
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )
- timeFrame
- Up to 30 Months
- description
- CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) \* 100.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC * Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum * At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated area * Age ≥18 years * Life expectancy of ≥6 months * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at study entry * Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5 x 10\^9 liter (L), hemoglobin ≥10 grams per deciliter (g/dL), and platelets ≥100 x 10\^9/L * Adequate hepatic function as defined by a total bilirubin ≤1.5 milligrams per deciliter (mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (or 5.0 x ULN in the case of liver metastases), and alkaline phosphatase (AP) ≤2.5 x ULN (or 5.0 x ULN in the case of liver metastases) * Adequate renal function as defined by a serum creatinine ≤1.5 x ULN, creatinine clearance ≥ 60 milliliters per minute (mL/min), or serum albumin ≥lower limit of normal (LLN) * Participant's relevant toxicities/effects of prior therapy \[surgery/radiation therapy (RT)\] must have recovered to a stable or chronic level * Participant agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Participants must notify the principal investigator if they themselves or their partner becomes pregnant. * Participant has provided signed Informed Consent Exclusion Criteria: * Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC. * Has received prior radiotherapy to \>25% of bone marrow * Has documented and/or symptomatic brain metastases * Has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry * Has received previous therapy with monoclonal antibodies * Has received previous therapy with any agent that targets the EGFR * Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the participant or study. * On chronic non-topical corticosteroid treatment for \>6 months at doses \>10 milligrams per day (mg/day) of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the participant or the study * Has a known dihydropyrimidine dehydrogenase deficiency * Has a known allergy to any of the treatment components * Has an acute or subacute intestinal occlusion * Has peripheral neuropathy ≥Grade 2 * Has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix * If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding * Has received a prior autologous or allogeneic organ or tissue transplantation * Has interstitial pneumonia or interstitial fibrosis of the lung * Has pleural effusion or ascites that causes ≥Grade 2 dyspnea * Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent
References
Publications (0)
Data not yet available
No reference posted for this study.