Phase 1
N=6
MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.
Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
Bottom Line
View on ClinicalTrials.gov: NCT01498952 ↗Enrolled (actual)
6
Serious AEs
33.3%
Results posted
Feb 2019
Primary outcome: Primary: Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) — 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MEDI-573 (1 of 3 doses) (Drug); Sorafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) |
1; 0 | — |
| PRIMARY Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) |
3; 3; 1; 1 | — |
| PRIMARY Phase 1b: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs |
2; 2; 1; 1; 0; 1 | — |
| PRIMARY Phase 1b: Number of Participants With Vital Signs Abnormalities Reported as TEAEs |
0; 2; 0; 1; 0; 1 | — |
| PRIMARY Phase 1b: Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs |
0; 0 | — |
| PRIMARY Phase 2: Time to Progression |
— | — |
| SECONDARY Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573 |
0; 0 | — |
| SECONDARY Phase 2: Best Overall Tumor Response |
— | — |
| SECONDARY Phase 2: Objective Response Rate |
— | — |
| SECONDARY Phase 2: Progression-free Survival (PFS) |
— | — |
| SECONDARY Phase 2: Change in Tumor Size |
— | — |
| SECONDARY Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1 |
1.05; 1.55 | — |
| SECONDARY Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1 |
195; 920 | — |
| SECONDARY Phase 1b and Phase 2: Area Under Serum Concentration-time Curve From Time Zero to Day 22 (AUC0-Day22) of MEDI-573 for Cycle 1 |
887; 6390 | — |
Summary
A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years or minimum age of consent per local regulations at the time of screening
- Unresectable or metastatic hepatocellular carcinoma
- ECOG Performance Status ≤ 2
- Life expectancy of ≥ 3 months;
Exclusion Criteria
- Child-Pugh Score for Cirrhosis Mortality > 7 points
- Prior or current system anti-cancer therapy for HCC, including cytotoxic, biologic, targeted or experimental therapy
- Prior local treatment for HCC less than 4 weeks prior to initiating study treatment
- Active second malignancy
- Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to initiating study treatment
- Thrombotic or embolic events within 6 months prior to initiating study treatment
- Ongoing pancreatitis
- Uncontrolled or refractory ascites
- Evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known leptomeningeal carcinomatosis
- Hepatic encephalopathy > Grade 1
- Active brain metastases with exceptions
- Poorly controlled diabetes mellitus
- Active coronary artery disease
- Uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT01498952). 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.