Single Patient Access (Compassionate Use) for Continued Treatment of RO7070179 for Adult Subjects With Advanced Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Clinical Trial

Official title:

Single Patient Access (Compassionate Use) for Continued Treatment of RO7070179 for Adult Subjects With Advanced Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT03496051
• Other study ID #: 17-01372
• Status: Available
• First received: April 4, 2018
• Last updated: April 4, 2018

Study information

• Verified date: April 2018
• Source: New York University School of Medicine
• Contact: Jennifer Wu, MD
• Phone: 212-263-6485
• Email: Jennifer.Wu[@]nyumc.org
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

This is a single-patient access (also referred to as Compassionate Use) setting for a patient who has been treated and benefited from RO7070179 while participating in a clinical study of RO7070179. The patient will receive the dose of RO7070179 at 6 mg/kg/week by IV infusion. Treatment cycles will be defined as 42 (6 weeks) days.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed Informed Consent Form

2. Ability to comply with the protocol, in the investigator's judgment

3. Diagnosis of hepatocellular carcinoma based on previous biopsy

4. Previously treated with RO7070179 and demonstrated a clinical benefit

Exclusion Criteria: N/A

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• RO7070179
The patient will receive the dose of RO7070179 at 6 mg/kg/week by IV infusion. The duration of infusion should be 30-60 min based on any prior infusion related reaction. Dose reduction will not occur as this is the lowest dose level of RO70070179. The treatment will be delayed only for grade 3 toxicity.

Locations

Country	Name	City	State
United States	NYU Perlmutter Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Roche-Genentech

Country where clinical trial is conducted

United States,