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Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical benefit rate

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Aiwu R He, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Food and Drug Administration

Study ID:

2009-268

NCT ID:

NCT01205828

Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • liver cancer
  • hepatocellular
  • temozolomide
  • veliparib
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007