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A Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00878449
First received: April 7, 2009
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC).


Condition Intervention Phase
Solid Tumors
Drug: ABT-263
Drug: etoposide/cisplatin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Assess the safety profile of ABT-263 when administered in combination with etoposide/cisplatin in subjects with Cancer. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics of ABT-263 when administered in combination with etoposide/cisplatin . [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Determine the maximum tolerable dose (MTD) of ABT-263 when administered in combination with etoposide/cisplatin. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Determine the recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with etoposide/cisplatin. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate preliminary data regarding progression free survival (PFS). [ Time Frame: Bi-monthly ] [ Designated as safety issue: No ]
  • Evaluate preliminary data regarding objective response rate (ORR). [ Time Frame: Bi-monthly ] [ Designated as safety issue: No ]
  • Evaluate preliminary data regarding time to tumor progression (TTP). [ Time Frame: Bi-monthly ] [ Designated as safety issue: No ]
  • Evaluate preliminary data regarding overall survival (OS). [ Time Frame: Bi-monthly ] [ Designated as safety issue: No ]
  • Evaluate preliminary data regarding duration of overall response. [ Time Frame: Bi-monthly ] [ Designated as safety issue: No ]
  • Evaluate preliminary data regarding Eastern Cooperative Oncology Group (ECOG) performance status. [ Time Frame: Bi-monthly ] [ Designated as safety issue: No ]
  • Evaluate biomarkers [ Time Frame: Bi-monthly ] [ Designated as safety issue: No ]
    Define the relationship between disease state (related to patient selection and monitoring), B-Cell Lymphoma 2 (Bcl-2) family protein expression, and potential response to the proposed therapy ABT-263 and etoposide/cisplatin.


Enrollment: 12
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-263 + etoposide/cisplatin Drug: ABT-263
150mg of ABT-263 is taken daily for 3 out of 21 days. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
Drug: etoposide/cisplatin
etoposide = 100 mg/m2 Days 1-3 of each Cycle; Max duration 6 cycles. cisplatin = 75 mg/m2 Day 1 of each Cycle; Max duration 6 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be greater then or equal to18 years of age;
  • For dose escalation subject must have histologically and/or cytologically documented cancer for which etoposide/cisplatin has been determined to be an appropriate therapy. For expanded safety cohort subject must have histologically and/or cytologically documented SCLC for which etoposide/cisplatin has been determined an appropriate therapy;
  • Subject has an ECOG performance score of less then or equal to 1; Evaluable and/or measurable disease by CT or MRI per RECIST criteria;
  • Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the 1st dose of study drug;
  • Must have adequate renal and hepatic function, per local laboratory reference range at Screening as follows:

    • ANC greater then or equal to 1500/mcL,
    • Platelets greater then or equal to 150,000/mm^3,
    • Hemoglobin greater then or equal to 10.0 g/dL,
    • Serum creatinine less then or equal to 1.5 mg/dL or calculated creatinine clearance greater then or equal to 50 mL/min; Na greater then 130 mmol/L,
    • Alkaline Phosphatase, AST and ALTless then or equal to 2.5 x ULN ;Bilirubin less then or equal to 1.5 x ULN.Subjects with liver mets may have ALP, AST and ALT less then or equal to 5.0 x ULN, Subjects with bone mets may have Alkaline Phosphatase less then or equal to 5.0 x ULN,
    • Subjects with Gilbert's Syndrome may have a Bilirubin greater then 1.5 x ULN,
    • Coagulation: aPTT, PT, less then or equal to 1.2 x ULN;
  • Life expectancy of at least 30 days;
  • Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a pregnancy test;
  • Female subjects not surgically sterile or postmenopausal (for at least one year) and non-vasectomized male subjects must practice at least one method of birth control.

Exclusion Criteria:

  • Subject exhibits evidence of other uncontrolled condition(s) including, but not limited to: active systemic infection, diagnosis of fever or neutropenia within 1 week of 1st dose;
  • Subject has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding;
  • Subject is currently receiving or requires anticoagulation therapy;
  • Subject has active immune thrombocytopenic purpura, autoimmune hemolytic anemia or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
  • Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis;
  • Subject has a significant history of CV disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease;
  • Female subject is pregnant or breast-feeding;
  • Subject has tested positive for HIV;
  • Subject has a history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent;
  • Subject has received any anti-cancer therapy within 14 days prior to 1st dose of study drug;
  • Subject has received steroid therapy for anti-neoplastic intent within 7 days prior to 1st dose of study drug;
  • Subject has received aspirin within 7 days prior to 1st dose of study drug;
  • Subject has received radio-immunotherapy within 6 months prior to 1st dose of study drug; Subject has received an antibody therapy or other biologics (with the exception of colony stimulating factors [G-CSF,GM-CSF] or erythropoietin) within 28 days prior to 1st dose of study drug;
  • Subject has a hypersensitivity to platinum-containing compounds or etoposide;
  • Subject has consumed grapefruit within 3 days prior to 1st dose of study drug.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878449

Locations
United States, Illinois
Site Reference ID/Investigator# 13323
Chicago, Illinois, United States, 60637
Site Reference ID/Investigator# 12841
Maywood, Illinois, United States, 60153
United States, Maryland
Site Reference ID/Investigator# 12303
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Site Reference ID/Investigator# 12305
Boston, Massachusetts, United States, 02215
Site Reference ID/Investigator# 20381
Boston, Massachusetts, United States, 02215
United States, Michigan
Site Reference ID/Investigator# 43505
Detroit, Michigan, United States, 48202
United States, New Jersey
Site Reference ID/Investigator# 13322
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Investigators
Study Director: Mack Mabry, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00878449     History of Changes
Other Study ID Numbers: M10-234
Study First Received: April 7, 2009
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cisplatin
Etoposide
Etoposide phosphate
Navitoclax
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014