A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)

December 9, 2022 updated by: Genentech, Inc.

A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma

This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma. Up to 90 patients with confirmed chondrosarcoma will be enrolled.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3002
        • Peter MacCallum Cancer Centre
  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Sarcoma Oncology Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to understand and willingness to sign a written informed consent document
  • Age ≥ 18 years
  • Histologic diagnosis of chondrosarcoma, verifiable after enrollment
  • Measurable disease
  • Previously treated or incurable disease without options for standard of care therapy
  • ECOG performance status of 0-2
  • Life expectancy of > 3 months
  • For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment

Exclusion Criteria:

  • Systemic therapy or radiotherapy within 4 weeks prior to Day 1
  • Prior therapy with agents targeting the DR5 apoptosis pathway
  • Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
  • Other invasive malignancies within 5 years prior to Day 1
  • Known active brain metastases
  • Uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring parenteral antibiotics at enrollment
  • Clinically significant, symptomatic cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade II or greater peripheral vascular disease, or history of major heart surgery within 6 months of Day 1, or any situation that would likely limit compliance with study requirements
  • Known to be positive for hepatitis C or hepatitis B surface antigen
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
  • Use of anticoagulation therapy
  • Participation in clinical trials or undergoing other investigational procedures within 30 days prior to Day 1
  • Pregnancy or breast feeding
  • Known sensitivity to any of the products administered during the study
  • Any disorder that compromises the ability of the patient to give written informed consent and/or comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRO95780
Drug: PRO95780
Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events
Objective response
Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations

Secondary Outcome Measures

Outcome Measure
Pharmacokinetic parameters
Progression-free survival
Overall survival
Duration of objective response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Sandra Skettino, M.D., Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2007

Primary Completion (Actual)

May 5, 2008

Study Completion (Actual)

May 5, 2008

Study Registration Dates

First Submitted

October 12, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APM4171g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chondrosarcoma

Clinical Trials on PRO95780

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe