Phase 2
Completed N=47
A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the Liver
Source: ClinicalTrials.gov NCT00906373 ↗Enrolled (actual)
47
Serious AEs
40.4%
Results posted
Jun 2018
Primary outcomePrimary: Progression Free Survival (PFS) — 2.9 months
Summary
To determine if IMC-A12 given in combination with Sorafenib is safe and effective for participants with advanced liver cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
2.9 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
4; 15; 6; 41 | — |
| SECONDARY Pharmacokinetic (PK): Maximum Concentration (Cmax) Cycle 1 |
— | — |
| SECONDARY PK: Minimum Concentration (Cmin) Cycle 1 |
— | — |
| SECONDARY PK: Half-Life (t1/2) Cycle 1 |
— | — |
| SECONDARY PK: Clearance (CL) Cycle 1 |
— | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve (AUC) Cycle 1 |
— | — |
| SECONDARY PK: Volume of Distribution at Steady State (Vss) Cycle 1 |
— | — |
| SECONDARY PK: Cmax Cycle 3 |
— | — |
| SECONDARY PK: Cmin Cycle 3 |
— | — |
| SECONDARY PK: t1/2 Cycle 3 |
— | — |
| SECONDARY PK: CL Cycle 3 |
— | — |
| SECONDARY PK: AUC Cycle 3 |
— | — |
| SECONDARY PK: Vss Cycle 3 |
— | — |
| SECONDARY Percentage of Participants With Complete Response (CR) and Partial Response (PR) [Objective Response Rate (ORR)] |
12.2 | — |
| SECONDARY Overall Survival (OS) |
11.6 | — |
| SECONDARY Time to Disease Progression (TTP) |
3.0 | — |
| SECONDARY Duration of Response (DOR) |
7.1 | — |
| SECONDARY The Number of Participants With Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity) |
— | — |
Eligibility Criteria
Inclusion Criteria
- The participant has histologically or cytologically confirmed, unresectable HCC
- The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. If a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
- The participant has not received prior systemic therapy for HCC. Participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery
- The participant has fasting serum glucose class II New York Heart Association (NYHA), unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
- The participant has experienced a hemorrhage or bleeding event ≥ National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4 weeks prior first dose of study therapy
Data sourced from ClinicalTrials.gov (NCT00906373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.