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NCT01205828 · ClinicalTrials.gov registry record · Phase 2

ABT-888 and Temozolomide for Liver Cancer

A Phase 2 study, sponsored by Georgetown University.

Terminated
Registry status
Phase 2
Development phase
16
Enrollment target

NCT01205828: Clinical Trial Phase 2 study, sponsored by Georgetown University.

NCT01205828 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01205828, a Phase 2 study, was terminated before completion, sponsored by Georgetown University.

TERMINATED
Registry status
Phase 2
Development phase
16 participants
Enrollment target

Study Summary

This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.

Primary Outcome

complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria

Interventions

  • DRUG Temozolomide
  • DRUG ABT-888

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2010-08
Est. Completion 2014-10
Phase Phase 2
Georgetown University

227 total trials

Why NCT01205828 stopped before completion

NCT01205828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.

NCT01205828 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01205828 about?

NCT01205828 is a clinical study titled "ABT-888 and Temozolomide for Liver Cancer". This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyrib...

What is the current status of trial NCT01205828?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2010-08. Estimated completion is 2014-10.

What interventions are being tested in trial NCT01205828?

The interventions under investigation include: Temozolomide (DRUG), ABT-888 (DRUG).

Who is sponsoring clinical trial NCT01205828?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01205828's enrollment target sits among peer trials

16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01205828, the US trial registry maintained by the National Library of Medicine. NCT01205828 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.