Clinical trial · Interventional
IMC-A12 in Treating Patients With Advanced Liver Cancer
A Phase 2 Study of IMC-A12 (NSC742460) in Hepatocellular Carcinoma
NCT00639509CI-TRIAL-00014671completedPhase 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)
This phase II trial is studying how well IMC-A12 works in treating patients with advanced liver cancer. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Recurrent Adult Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cixutumumab | Biological | Cixutumumab | ALIAS |
| computed tomography | Procedure | — | UNRESOLVED |
| contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (monoclonal antibody therapy)
- description
- Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: cixutumumab
- Procedure: computed tomography
- Procedure: contrast-enhanced magnetic resonance imaging
Primary outcomes (2)
- measure
- PFS Rate
- timeFrame
- At 4 months
- description
- PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon's optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed hepatocellular carcinoma * Unresectable, locally advanced, or metastatic disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Child's Pugh score A5, A6, B7, or B8 * No known brain metastases * No history of primary CNS tumors * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \> 3 months * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcL * Platelet count ≥ 75,000/mcL * Total bilirubin ≤ 2 times upper limit of normal (ULN) * AST/ALT ≤ 2.5 times ULN * PT/INR ≤ 1.7 times ULN * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min * Fasting serum glucose ≤ 125 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinical encephalopathy * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12 * No poorly controlled diabetes mellitus * Patients with a history of diabetes mellitus are eligible provided their blood glucose is within normal range (fasting blood glucose \< 120 mg/dL OR below ULN) and patient is on a stable dietary or therapeutic regimen for this condition * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would preclude compliance with study requirements * No history of seizures not well controlled with standard medical therapy * No history of stroke * No history of another primary cancer except for the following: * Curatively resected nonmelanoma skin cancer * Curatively treated carcinoma in situ of the cervix * Other primary solid tumor with no known active disease present that in the opinion of the investigator would not affect treatment outcome * Prior local therapy (i.e., surgery, radiotherapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) allowed provided the target lesion has not been treated with local therapy and/or the target lesion within the field of local therapy has shown an increase of ≥ 25% in size * At least 4 weeks since prior local therapy * No prior systemic therapy except for sorafenib tosylate * No prior agents targeting the IGF or IGF-1R pathway * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.