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

NCT00724100 | Terminated Phase 1

• 1 other identifier: AMRI-564-101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer

Keywords

Malignancy; Solid tumor; Tubulin inhibitor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose and dose limiting toxicity.

  Every treatment cycle

Secondary Outcomes (1)

• Anti-tumor activity (objective tumor response, time to progression, duration of response)

  Following every even-numbered cycle

Interventions

ALB 109564(a) (12´-methylthiovinblastine dihydrochloride) DRUG

Starting dose is 1.2 mg/m2. Standard dose increase, in the absence of limiting toxicity, is 50%. Each dose of ALB 109564(a) will be administered by intravenous infusion once every 3 weeks (21-day cycle) over a period of time up to approximately 30 minutes. Number of cycles: Maximum of 12, until disease progression, or unacceptable toxicity develops. Greater than 12 cycles if disease has not progressed after 12 cycles, with Investigator's and Sponsor's approvals.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Albany Molecular Research, Inc.: lead
• Westat: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Montefiore-Einstein Cancer Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

ALB 109564a

Study Officials

• Daniel Cho, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Geoffrey Shapiro, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Eunice L. Kwak, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Sridhar Mani, MD

  Montefiore-Einstein Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 27, 2014

Record last verified: 2011-09

Locations

US (2)