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COMPLETEDPHASE1

A Pharmacodynamic Study of AV-299 (Formerly SCH 900105) in Subjects With Advanced Solid Tumors Who Have Liver Metastases

A Pharmacodynamic Study of AV-299 (Formerly SCH 900105) in Subjects With Advanced Solid Tumors Who Have Liver Metastases (P05670)

NCT00969410•AVEO Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

A pharmacodynamic study to evaluate the effect of AV-299 on exploratory pharmacodynamic markers in subjects with advanced solid tumors who have liver metastases. To evaluate safety and tolerability of AV-299 administered IV in subjects with advanced solid tumors who have liver metastases.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to give written informed consent and be able to adhere to dose and visit schedules.
•Diagnosis of an advanced colorectal, breast, gastric/esophageal or pancreatic cancer with liver metastases that are amenable to biopsy.
•Histological or cytological evidence of malignancy.
•Advanced metastatic colorectal, breast, gastric/esophageal or pancreatic cancer that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists, or for which subject is not a candidate for, or is unwilling to undergo standard therapy.
•Note: Additional tumor histologies may be eligible based on available HGF/c-Met pathway data and approval by the Sponsor.
•Disease that is currently not amenable to curative surgical intervention.
•Male or female and ≥ 18 years of age.
•ECOG performance status of 0-1.
•Measurable p-Met by immunohistochemistry in archived or otherwise available tumor sample.
•Female subjects of childbearing potential must have negative pregnancy test within 5 days prior to first dose of study drug.
+7 more criteria

Exclusion Criteria

•Women who are breast-feeding, pregnant, or intend to become pregnant.
•Hematologic malignancies.
•Any of the following within 6 months prior to administration of study drug:
•Myocardial infarction (MI), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or seizure disorder.
•Serious/symptomatic active infection, or infection requiring antibiotics, within 14 days prior to first dose of study drug.
•Persistent, unresolved CTCAE v3.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, and Grade 2 sensory peripheral neuropathy) associated with previous treatment.
•Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to administration of first dose of study drug.
•Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results.
•Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy.
•Known active hepatitis B or C.
+8 more criteria

Locations (1)

Investigational Site 1

Barcelona, Spain

Key Dates

Start Date

August 1, 2009

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

April 12, 2012

Enrollment

ACTUAL participants

Conditions

Malignant Solid TumourLiver Metastases

Interventions

AV-299

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Pharmacodynamic Study of AV-299 (Formerly SCH 900105) in Subjects With Advanced Solid Tumors Who Have Liver Metastases

Inclusion Criteria

Exclusion Criteria

Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

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Stereotactic Magnetic Resonance Guided Radiation Therapy

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