Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC

NCT01379521 | Terminated Phase 2 Results DMC

• 1 other identifier: CRAD001OHK02
• Study Type: interventional
• Target: 65
• Locations: 3 countries
• Sites: 5

Brief Summary

This study will evaluate the role of everolimus in combination with local Transcatheter Arterial Chemoembolization (TACE) procedure in patients with localized unresectable Hepatocellular Carcinoma (HCC).

Conditions

Hepatocellular Carcinoma

Keywords

Localised; unresectable; chemoembolization

Outcome Measures

Primary Outcomes (1)

• Time to Progression (TTP) Based on the Modified RECIST Criteria

  Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on modified RECIST criteria. Progressive Disease: \>20% increase in sum of the longest diameters (SLD) of "viable" target lesion (arterial phase enhancement)

  3, 6, 12, 18 and 24 months

Secondary Outcomes (6)

• Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on the Modified RECIST

  6, 12 months, end of study

• Time to Progression Based on Original RECIST

  6, 12 months, end of study

• Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on Original RECIST

  6, 12 months, end of study

• Overall Survival (OS)

  6, 12, 18, 24, 30 months

• Incidences of Cumulative New Nodular Recurrence, Portal Vein Invasion and Extra Hepatic Metastases

  30 months

Study Arms (2)

everolimus + TACE

EXPERIMENTAL

everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)

Drug: everolimus

placebo + TACE

PLACEBO COMPARATOR

Placebo by mouth + transcatheter arterial chemoembolization (TACE)

Drug: everolimus placebo

Interventions

everolimus DRUG

Also known as: RAD001, Afinitor®)

everolimus + TACE

everolimus placebo DRUG

placebo + TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed hepatocellular carcinoma limited to liver and not suitable for resection, liver transplant, or radiofrequency ablation.
• Intermediate stage (stage B) (according to recognized guidelines) and suitable for TACE therapy
• At least one nodule between \> 2cm and ≤ 15cm in diameter with no vascular invasion or abdominal lymph node or distant metastases.
• Must have 1 tumor which can be measured in 1 dimension according to specified criteria (RECIST and mRECIST) and has not previously been treated with any type of therapy.
• ECOG performance status \< 2cm
• Cirrhotic status of Child-Pugh class A or early B
• HBV-DNA or HBsAg positive at screen or baseline: preventative treatment with anti-viral started 1-2 weeks prior to receiving study drug

You may not qualify if:

• Any local and/or investigational drugs within 28 days prior to randomization
• Active bleeding during the last 28 days prior to screening including variceal bleeding
• Prior therapy with mTOR inhibitors
• Tumor burden of \> 60% liver involvement
• Prior systemic or local therapy including TACE except for the first TACE at Day 0), surgery or liver transplantation
• Failed first TACE at Day 0, Cycle 1 for any reason
• Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
• Alcohol intake of 80 grams per day
• Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from surgery
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Kaohsiung, Taiwan, 83301, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 807, Taiwan

Location

Novartis Investigative Site

Linkou District, 33305, Taiwan

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 23, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 3, 2017
• Results First Posted: May 3, 2017

Record last verified: 2017-04

Locations

HK (1); TW (3); TH (1)