A Trial of ALB 109564(a) in Subjects With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Cancer

In brief

The purpose of this study is to determine the maximum tolerated dose of ALB 109564(a), a novel tubulin inhibitor, and to assess safety, pharmacokinetics, and anti-tumor activity in subjects with advanced solid tumors.

Key facts

Study ID

NCT00724100

Run by

Albany Molecular Research, Inc.

People needed

46

Starts

2008-09-01

Expected to finish

2010-12-01

Last updated by the study team

2014-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years of age.
• Histologically or cytologically confirmed solid tumor that is metastatic or progressive and for whom no standard therapy holds curative potential.
• Evaluable disease, measurable by either imaging using Response Evaluation Criteria in Solid Tumors (RECIST) or tumor marker(s).
• ECOG Performance Status of ≤ 2.
• Life expectancy of > 12 weeks.
• Laboratory values:
• Absolute neutrophil count ≥ 1,500 cells/μL.
• Platelets ≥ 100,000 cells/μL.
• Total bilirubin ≤ 1.5 × ULN.
• AST (SGOT) ≤ 2.5 × ULN.
• ALT (SGPT) ≤ 2.5 × ULN.
• Serum creatinine ≤ 1.5 mg/dL, or a measured creatinine clearance of ≥ 50 mL/min.
• Subjects with primary liver cancer or hepatic metastasis are eligible, if the following criteria are met:
• Total bilirubin ≤ 1.5 mg/dL.
• AST (SGOT) and ALT (SGPT) ≤ 5 × ULN.
• Severe liver dysfunction (Child-Pugh Class C or uncompensated Class B with persistent encephalopathy, persistent ascites, prothrombin time > 1.5 × ULN) is not present.
• Ascites, if present, is managed with diuretic agents or repeated paracentesis (required no more frequently than once per month).
• Esophageal bleeding and varices, if present, have been sclerosed or banded, and no bleeding episodes have occurred during the prior 6 months.
• Subjects with asymptomatic treated brain metastasis (surgical resection or radiotherapy) are eligible, if neurologically stable and have been off steroids and anticonvulsants required for symptom control for at least 3 months before Cycle 1, Day 1.

You may not qualify if…

• Women who are pregnant or lactating or of child-bearing potential, but not using adequate contraception.
• Receipt of chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before starting ALB 109564(a).
• Presence of acute or chronic adverse toxicity due to prior chemotherapy that has not resolved to ≤ Grade 1, as determined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.
• Major surgery within 4 weeks before starting ALB 109564(a).
• Peripheral neuropathy of Grade ≥ 2 by CTCAE v3.0.
• Evidence of autonomic or other neuropathic syndromes, including chronic constipation.
• Confirmed diagnosis of HIV.
• Active, uncontrolled infection or systemic inflammatory disease.
• Active hepatitis B or C or other active liver disease (other than malignancy).
• Contraindication to a vinca alkaloid.
• Use of any investigational agent within 4 weeks of starting ALB 109564(a).
• Uncontrolled intercurrent illness that would jeopardize the subject's safety, interfere with the objectives of the protocol, or limit the subject's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Montefiore-Einstein Cancer Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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