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Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01233505
Recruitment Status : Terminated
First Posted : November 3, 2010
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase I trial is studying the side effects and the best dose of veliparib when given together with capecitabine and oxaliplatin in treating patients with advanced solid tumors. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Pancreas Adenocarcinoma of the Stomach BRCA1 Mutation Carrier BRCA2 Mutation Carrier Ovarian Mucinous Cystadenocarcinoma Recurrent Breast Cancer Recurrent Colon Cancer Recurrent Gastric Cancer Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Recurrent Pancreatic Cancer Recurrent Rectal Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Stage IV Colon Cancer Stage IV Gastric Cancer Stage IV Ovarian Epithelial Cancer Stage IV Ovarian Germ Cell Tumor Stage IV Pancreatic Cancer Stage IV Rectal Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: veliparib Drug: capecitabine Drug: oxaliplatin Other: pharmacological study Other: laboratory biomarker analysis Phase 1

Detailed Description:


I. To determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of ABT-888 (veliparib) in combination with oxaliplatin and capecitabine in advanced solid tumors.


I. To evaluate the pharmacokinetics of ABT-888, oxaliplatin, and capecitabine when administered concomitantly.

II. To evaluate the safety and tolerability of the ABT-888 in combination with capecitabine and oxaliplatin.

III. To assess for evidence of anti-tumor activity with this combination, per tumor measurements using RECIST criteria, in these patients.


I. To assess the inhibition of poly(ADP-ribose) polymerase (PARP) in peripheral blood mononuclear cells secondary to treatment with ABT-888.

II. To determine the pharmacokinetics of ABT-888 in combination with oxaliplatin and capecitabine and the relation to treatment side effects.

OUTLINE: This is a dose-escalation study of veliparib.

Patients receive veliparib orally (PO) twice daily and capecitabine PO twice daily on 1-7 and 15-21, and oxaliplatin intravenously (IV) over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and urine sample collection at baseline and periodically during study for pharmacokinetic and poly (ADP-ribose) polymerase (PARP) inhibition studies.

After completion of study therapy, patients are followed up for 30 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of ABT-888 in Combination With Oxaliplatin and Capecitabine in Advanced Solid Tumors
Study Start Date : October 2010
Actual Primary Completion Date : October 2013

Arm Intervention/treatment
Experimental: Treatment (veliparib, capecitabine, oxaliplatin)
Patients receive veliparib PO twice daily and capecitabine PO twice daily on 1-7 and 15-21, and oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: veliparib
Given PO
Other Name: ABT-888

Drug: capecitabine
Given PO
Other Names:
  • CAPE
  • Ro 09-1978/000
  • Xeloda

Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Maximum-tolerated (MTD) dose of veliparib in combination with oxaliplatin and capecitabine as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 28 days ]
    MTD defined as the dose level at which less than one-third of patients experience a dose-limiting toxicity (DLT).

  2. Dose-limiting toxicities of veliparib in combination with oxaliplatin and capecitabine as assessed by NCI CTCAE version 4.0 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics of veliparib administered concomitantly with oxaliplatin and capecitabine [ Time Frame: At baseline, at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours of days 1 and 7 ]
    Graphical displays of individual, mean, and median plasma concentration over time will be presented at each ABT-888 dose level and overall in the entire group. Descriptive summaries for each pharmacokinetic endpoint will be presented by ABT-888 dose level.

  2. Safety and tolerability as assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 30 days ]
    Reported in tabular format, both per dose level, as well as in the aggregate cohort.

  3. Anti-tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 30 days ]
    Anti-tumor responses will be summarized using descriptive statistics and will be presented in tables. In addition, two-sided 90% confidence intervals for the proportions of subjects with a confirmed anti-tumor response will be obtained.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed solid tumors that fulfill ≥ 1 of the following criteria:

    • BRCA1/2 mutation and a BRCA-related malignancy

      • Patients without a known BRCA mutation must have a probability of harboring a BRCA gene mutation as assessed by BRCAPRO computer program
      • Patients with a probability of having genetic mutation ≥ 20% or a BRCA mutation based on a non-Myriad test, must have a formal BRCA testing by Myriad Genetic Laboratories
      • Patients with known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance
      • Patients who refuse BRCA testing not allowed unless they have another acceptable histology
    • First- or second-line metastatic colorectal cancer
    • Any-line metastatic mucinous ovarian cancer
    • Any line of other metastatic gastrointestinal malignancies in which oxaliplatin has shown some activity (i.e., gastric or pancreatic adenocarcinoma)
  • Patients with uncontrolled CNS metastasis are not eligible; patients with CNS metastases who have had them treated and are stable for > 3 months will be eligible; patients must be off steroid treatment prior to study enrollment
  • Measurable disease

    • Patients with ovarian cancer who have a pre-treatment CA 125 level of at least twice the upper limit of normal allowed
  • ECOG performance status (PS) 0-2 (Karnofsky 60-100%)
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases)
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Fertile patients must use adequate contraception (i.e., hormonal, barrier method of birth control, or abstinence)
  • Not pregnant or nursing
  • Negative pregnancy test
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in study
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • No history of positive serology for hepatitis A, B, or C, liver disease, or other forms of hepatitis or cirrhosis
  • Patients who have active seizures or history of seizures are ineligible
  • No condition that impairs the ability to swallow and retain veliparib capsules, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • No malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction
  • No peripheral neuropathy ≥ grade 2
  • No prolonged QTC > 450 msec (male) or QTC > 470 (female)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Recovered from adverse events of prior therapy or prior surgical procedures

    • Patients with chronic grade 1 or 2 adverse events that are not expected to improve are allowed at investigator's discretion
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • At least 4 weeks since prior radiotherapy with no > 35% of marrow irradiation
  • Prior fluoropyrimidine allowed
  • Prior veliparib allowed provided it was part of a single- or limited-dosing study, such as a phase 0 study
  • Prior capecitabine allowed provided patient tolerated 3500 mg/m² for 7 days out of 14 days
  • No other prior investigational agents
  • No prior oxaliplatin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01233505

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United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: William Schelman University of Wisconsin, Madison

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Responsible Party: National Cancer Institute (NCI) Identifier: NCT01233505    
Other Study ID Numbers: NCI-2011-02543
NCI-2011-02543 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
C010903 ( Other Identifier: University of Wisconsin Hospital and Clinics )
8604 ( Other Identifier: CTEP )
P30CA014520 ( U.S. NIH Grant/Contract )
U01CA062491 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: October 2013
Additional relevant MeSH terms:
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Breast Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Neoplasms, Germ Cell and Embryonal
Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Cystadenocarcinoma, Mucinous
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms