ABT-888 and Temozolomide for Liver Cancer
This study is currently recruiting participants.
Verified October 2011 by Georgetown University
Sponsor:
Georgetown University
Collaborator:
Abbott
Information provided by (Responsible Party):
Ruth He, Georgetown University
ClinicalTrials.gov Identifier:
NCT01205828
First received: September 18, 2010
Last updated: October 4, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: temozolomide + ABT-888 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib |
Resource links provided by NLM:
Further study details as provided by Georgetown University:
Primary Outcome Measures:
- clinical benefit rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria
Secondary Outcome Measures:
- overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]the number of days between a patient's enrollment and his/her date of death
- Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]The number of days between a patient's enrollment and his/her disease progression
- Safety assessment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Record of all toxicities graded according to the NCI CTCAE version 3.0
- Biomarker analysis [ Time Frame: 2 months ] [ Designated as safety issue: No ]Markers in blood or tissue that are looked at will be classified as yes (present)or no (not present)
| Estimated Enrollment: | 49 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: temozolomide + ABT-888
Temozolomide and ABT-888
|
Drug: temozolomide + ABT-888
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months). Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathological confirmation of HCC or noninvasive criteria following AASLD guidelines
- Measurable or evaluable disease based on RECIST criteria
- Progressive disease on sorafenib or intolerance to sorafenib
- ECOG performance status 0-2
- Child Pugh Class A or B
- Adequate hepatic, bone marrow, and renal function
Exclusion Criteria:
- Prior ABT-888 or other PARP inhibitor treatment
- Anticipation of need for major surgery during the study
- Any of the following within 6 months before enrollment: myocardial infarction, severe/unstable angina, congestive heart failure, or severe pulmonary disease
- Women who are pregnant or lactating
- Women and men of child-bearing potential who are not using a reliable form of contraception
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 and temozolomide
- Concurrent malignancy (i.e. malignancy other than hepatocellular cancer) unless 1) the subject has been curatively treated and disease free for at least 2 years or 2) the cancer was non-melanoma skin cancer or early cervical cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding active hepatitis B or C) or psychiatric illness/ social situations that would limit compliance with study requirements
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205828
Contacts
| Contact: Erin Sandene, BSN | 202-687-2007 | eks43@georgetown.edu |
| Contact: Lisa Ley, MSN | 202-687-6653 | leyl@georgetown.edu |
Locations
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Erin Sandene, BSN 202-687-2007 eks43@georgetown.edu | |
| Contact: Lisa Ley, MSN 202-687-6653 leyl@georgetown.edu | |
| Principal Investigator: Aiwu R He, MD PhD | |
Sponsors and Collaborators
Georgetown University
Abbott
Investigators
| Principal Investigator: | Aiwu R He, MD PhD | Georgetown University |
More Information
No publications provided
| Responsible Party: | Ruth He, Assistant Professor of Medicine, Georgetown University |
| ClinicalTrials.gov Identifier: | NCT01205828 History of Changes |
| Other Study ID Numbers: | 2009-268 |
| Study First Received: | September 18, 2010 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Georgetown University:
|
liver cancer hepatocellular temozolomide veliparib |
Additional relevant MeSH terms:
|
Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Adenocarcinoma Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013