Completed

A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer

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What is being tested

ABT-510

Drug
Who is being recruted

Endocrine System Diseases+2

+ Head and Neck Neoplasms

+ Neoplasms

Over 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: April 2005
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2005

Actual date on which the first participant was enrolled.

This is a phase Ib/II, single-center, open-label study designed to assess the safety, tolerability, pharmacokinetics, and biologic efficacy of ABT-510 (thrombospondin). Participants will be patients with incurable head and neck cancer. Patients will begin at a fixed dose level of thrombospondin subcutaneously twice daily. Cycles of treatment are 28 days (4 weeks). Patients will be treated with thrombospondin until progression of tumor or toxicity.

Official TitleA Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer
NCT00113334
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteThyroid Diseases

Criteria

12 inclusion criteria required to participate
Patient has histologically proven squamous cell carcinoma of the head and neck that is not amenable to curative therapy, including radiation or surgery (including surgery following induction chemotherapy or chemo-radiation).
Patient's tumor is biopsy accessible.
Patient has a Karnofsky performance status >/= 70.
Patient has adequate bone marrow function: White blood count (WBC) >/= 3,000 cells/mm3, absolute neutrophil count (ANC) >/= 1,500 cells/mm3, platelet count >/= 100,000 cells/mm3, Hgb >/= 9.0 g/dL.
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11 exclusion criteria prevent from participating
No biopsy accessible tissue.
Patient has received prior radiation therapy to biopsy site within the past 3 months. (Patient may have received palliative radiation within the past 2 weeks, but not to the biopsy site.)
Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent.
Patient requires total parenteral nutrition with lipids.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Texas MD Anderson Cancer Center

Houston, United StatesOpen University of Texas MD Anderson Cancer Center in Google Maps
CompletedOne Study Center