Trials Sponsors Conditions Drugs Pricing

Conditions

Cancer of Liver Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaCancer of LiverPXS-5505

Outcome Measures

Primary Outcomes (1)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measured by adverse event severity and quantity
10 years

Study Arms (1)

Experimental

EXPERIMENTAL

Open label safety and tolerability assessment of PXS-5505: (PXS-5505) 100-200mg BID (Atezolizumab) 1200mg every 3 weeks (Bevacizumab) 15mg/kg every 3 weeks

Drug: PXS-5505 and Atezolizumab and Bevacizumab

Interventions

PXS-5505 and Atezolizumab and BevacizumabDrug

Open label safety and tolerability assessment of PXS-5505 incorporating first-line combination therapy Atezolizumab and Bevacizumab

Experimental

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
PXS-5505 and Atezolizumab and Bevacizumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient or legally authorized representative must be able to understand and willing to sign an IRB approved written informed consent document.
Patients must be 18 years or older

Sponsors & Collaborators

University of Rochester
Otherlead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

atezolizumabBevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Study Officials

Nabeel Badri
Univ. of Rochester Wilmot Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Senior Instructor - Department of Medicine , Hematology/Oncology (SMD)

Study Record Dates

First Submitted

September 15, 2021

First Posted

November 5, 2021

Study Start

September 20, 2022

Actual (reported)

You may not qualify if:

Patient with any histologic variant of HCC such as fibrolamellar, sarcomatous, or mixed cholangiocarcinoma and HCC.
Patient has a history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, carcinoma in situ of the cervix, or prostate cancer that does not require treatment.
Patient who received a previous systemic therapy for hepatocellular carcinoma or has tumor recurrence sooner than 6 months after completion of the last dose of therapy.
Patient who is receiving any other investigational agent
Patient has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXS-5505, Atezolizumab, or Bevacizumab
Patient with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, any clinically active malabsorption syndrome, inflammatory bowel disease, any condition that increases the risk of severe gastrointestinal toxicity, or psychiatric illness/social situations that would limit compliance with study requirements
Has current active autoimmune disease, or a documented history of autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, resolved childhood asthma/atopy, hypothyroidism on thyroid supplementation, and type 1 diabetics would be exception to this rule.
Patients who are eligible for liver transplantation
Has had an allogenic tissue/solid organ transplant.
Has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
Has received or plans to receive a live vaccine within 30 days prior to the first administration of study medication. Flu vaccines that do not contain live virus are permitted.
Has known active Hepatitis B or C.
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
+10 more criteria

Study Stopped

Trial of PXS-5505 Combined With First Line Atezolizumab Plus Bevacizumab For Treating Patients With Unresectable Hepatocellular Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Experimental

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Experimental

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations