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Adenocarcinoma of the PancreasPhase 1NCT01233505

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

A Phase 1 study testing veliparib, capecitabine and oxaliplatin in people with Adenocarcinoma of the Pancreas and Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
veliparib, capecitabine and oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Oct 2010to Oct 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 48Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: A Phase I Study of ABT-888 in Combination With Oxaliplatin and Capecitabine in Advanced Solid Tumors

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

SECONDARY OBJECTIVES:

  1. 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.

TERTIARY OBJECTIVES:

  1. 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.

Being tested
veliparib, capecitabine, oxaliplatin, pharmacological study, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms, Colonic Neoplasms, Stomach Neoplasms, Carcinoma, Ovarian Epithelial, Pancreatic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • veliparibDrug

    Also called ABT-888

    Given PO

  • capecitabineDrug

    Also called CAPE, Ro 09-1978/000, Xeloda

    Given PO

  • oxaliplatinDrug

    Also called 1-OHP, Dacotin, Dacplat, Eloxatin

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01233505
Study groupRoleWhat they receive
Treatment (veliparib, capecitabine, oxaliplatin)ExperimentalPatients 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.
Receives: Drug: veliparib; Drug: capecitabine; Drug: oxaliplatin; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    MTD defined as the dose level at which less than one-third of patients experience a dose-limiting toxicity (DLT).

    Measured: 28 days

  2. Dose-limiting toxicities of veliparib in combination with oxaliplatin and capecitabine as assessed by NCI CTCAE version 4.0

    Measured: 28 days

Secondary outcomes (3)

  1. Pharmacokinetics of veliparib administered concomitantly with oxaliplatin and capecitabine

    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.

    Measured: At baseline, at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours of days 1 and 7

  2. Safety and tolerability as assessed by NCI CTCAE version 4.0

    Reported in tabular format, both per dose level, as well as in the aggregate cohort.

    Measured: Up to 30 days

  3. Anti-tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST)

    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.

    Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01233505
Sponsor's protocol ID
NCI-2011-02543
Other IDs
NCI-2011-02543, CDR0000687938, C010903, 8604, P30CA014520, U01CA062491
Status last verified
Oct 2013
First submitted
2 Nov 2010
Last updated
2 Apr 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing veliparib, capecitabine and oxaliplatin in people with Adenocarcinoma of the Pancreas and Adenocarcinoma of the Stomach, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 48 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01233505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.

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