Clinical trial NCT01498952: MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.
Official title: A Phase 1b/2, Open-label, Randomized Study of MEDI-573 in Combination With Sorafenib Verses Sorafenib Alone in Adult Subjects With Unresectable or Metastatic Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
Keywords: HCC, liver cancer, hepatocellular carcinoma, MEDI-573, anti-IGF
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)
timeFrame: Day 1 to Day 21 of Cycle 1
measure: Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
timeFrame: From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months)
measure: Phase 1b: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
timeFrame: From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months)
measure: Phase 1b: Number of Participants With Vital Signs Abnormalities Reported as TEAEs
timeFrame: From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months)
measure: Phase 1b: Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs
timeFrame: From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months)
measure: Phase 2: Time to Progression
timeFrame: From Day 1 until documentation of progressive disease (approximately 15 months)
Secondary outcomes:
measure: Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573
timeFrame: Predose on Day 1 of every treatment cycle; end of treatment; Days 30, 60 and 90 post treatment; every 3 months post treatrment till end of study (approximately 15 months)
measure: Phase 2: Best Overall Tumor Response
timeFrame: From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months)
measure: Phase 2: Objective Response Rate
timeFrame: From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months)
measure: Phase 2: Progression-free Survival (PFS)
timeFrame: From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months)
measure: Phase 2: Change in Tumor Size
timeFrame: From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months)
measure: Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1
timeFrame: Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose)
measure: Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1
timeFrame: Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose)
measure: 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
timeFrame: Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose)
Other outcomes:
Locations:
city: Oxnard
country: United States
facility: Research Site
state: California
city: Golden Springs
country: United States
facility: Research Site
state: Colorado
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
Study officials:
affiliation: MedImmune LLC
name: Susan Perez, MD
role: STUDY_DIRECTOR
References: