CompletedPhase 1

A Study of ABT-806 in Subjects With Advanced Solid Tumor Types

United States49 participantsStarted 2010-11

Plain-language summary

This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive. * Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent. * Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. * Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. * Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) . Exclusion Criteria: * Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort. * Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806. * Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806. * Subject has recei…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety (Number of subjects with adverse events and/or dose-limiting toxicities)

Timeframe: At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)

Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort

Timeframe: Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit

Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort

Timeframe: Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up

Trial details

NCT IDNCT01255657

SponsorAbbVie (prior sponsor, Abbott)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-11

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