跳至主要内容
临床试验/NCT01233505
NCT01233505终止1 期

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

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
16
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Treatment (veliparib, capecitabine, oxaliplatin)

Experimental

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.

干预措施: veliparib (Drug)

Treatment (veliparib, capecitabine, oxaliplatin)

Experimental

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.

干预措施: capecitabine (Drug)

Treatment (veliparib, capecitabine, oxaliplatin)

Experimental

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.

干预措施: oxaliplatin (Drug)

Treatment (veliparib, capecitabine, oxaliplatin)

Experimental

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.

干预措施: pharmacological study (Other)

Treatment (veliparib, capecitabine, oxaliplatin)

Experimental

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.

干预措施: laboratory biomarker analysis (Other)

结局指标

主要结局

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

时间窗: 28 days

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

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

时间窗: 28 days

次要结局

  • Pharmacokinetics of veliparib administered concomitantly with oxaliplatin and capecitabine(At baseline, at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours of days 1 and 7)
  • Safety and tolerability as assessed by NCI CTCAE version 4.0(Up to 30 days)
  • Anti-tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST)(Up to 30 days)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

已完成
1 期
Veliparib and Topotecan With or Without Carboplatin in Treating Patients With Relapsed or Refractory Acute Leukemia, High-Risk Myelodysplasia, or Aggressive Myeloproliferative DisordersAdult Acute Megakaryoblastic LeukemiaAdult Acute Monoblastic LeukemiaAdult Acute Monocytic LeukemiaAdult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Adult Acute Myeloid Leukemia With MaturationAdult Acute Myeloid Leukemia With Minimal DifferentiationAdult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2AAdult Acute Myeloid Leukemia Without MaturationAdult Acute Myelomonocytic LeukemiaAdult ErythroleukemiaAdult Pure Erythroid LeukemiaChronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 PositiveDe Novo Myelodysplastic SyndromeHematopoietic and Lymphoid Cell NeoplasmRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromeChronic Myelomonocytic LeukemiaPolycythemia VeraEssential ThrombocythemiaMyelodysplastic Syndrome
NCT00588991National Cancer Institute (NCI)12
进行中(未招募)
1 期
Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney DysfunctionBreast CarcinomaCarcinoma of Unknown PrimaryEndometrial CarcinomaLung CarcinomaMalignant Head and Neck NeoplasmMalignant Testicular NeoplasmMetastatic Malignant Solid NeoplasmOvarian CarcinomaUnresectable Malignant NeoplasmLiver FailureMelanomaEsophageal CarcinomaRenal FailureUrothelial Carcinoma
NCT01366144National Cancer Institute (NCI)94
已完成
1 期
Veliparib in Combination With Carboplatin and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid TumorsAdult Solid NeoplasmEstrogen Receptor NegativeEstrogen Receptor PositiveHER2/Neu NegativeMale Breast CarcinomaProgesterone Receptor NegativeRecurrent Breast CarcinomaStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast CancerTriple-Negative Breast Carcinoma
NCT01281150National Cancer Institute (NCI)22
已完成
1 期
Veliparib, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid CancerAdult Solid NeoplasmBRCA1 Mutation CarrierBRCA2 Mutation CarrierHereditary Breast and Ovarian Cancer Syndrome
NCT00535119National Cancer Institute (NCI)107
已完成
1 期
Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid TumorsAdult B Acute Lymphoblastic LeukemiaAdult Nasal Type Extranodal NK/T-Cell LymphomaAdult Solid NeoplasmAngioimmunoblastic T-Cell LymphomaCutaneous B-Cell Non-Hodgkin LymphomaExtranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueHepatosplenic T-Cell LymphomaIntraocular LymphomaLymphomatous Involvement of Non-Cutaneous Extranodal SiteMature T-Cell and NK-Cell Non-Hodgkin LymphomaNodal Marginal Zone LymphomaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-Cell Leukemia/LymphomaRecurrent Cutaneous T-Cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaChronic Lymphocytic LeukemiaAnaplastic Large Cell LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides and Sezary SyndromeRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Plasma Cell MyelomaSmall Intestinal LymphomaSplenic Marginal Zone LymphomaTesticular LymphomaWaldenstrom Macroglobulinemia
NCT01326702National Cancer Institute (NCI)43
Veliparib, Oxaliplatin, and Capecitabine in Treating... | 临床试验