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A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies
This study is currently recruiting participants.
Verified by Abbott, November 2008
Sponsors and Collaborators: Abbott
Genentech
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00445198
  Purpose

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose.

The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy.


Condition Intervention Phase
Small Cell Lung Cancer
Non-Hematological Malignancies
Drug: ABT-263
Phase I
Phase II

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety assessment [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off ] [ Designated as safety issue: Yes ]
  • Dose limiting toxicity determination [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose determination [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile evaluation [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extended safety assessment at the recommended Phase 2 dose [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off ] [ Designated as safety issue: Yes ]
  • Preliminary efficacy assessment [ Time Frame: Repeating sequence of 14 days on therapy and 7 days off ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: April 2007
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
40 SCLC patients: Experimental Drug: ABT-263
Dose escalation (CRM-design) starting at 10mg.

  Eligibility

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

Inclusion Criteria:

  • The subject must be >=18 years of age.(Phase 1 & 2a)
  • Histologically documented diagnosis of small cell lung cancer (North America & UK) or other non-hematological malignancy (North America only).(Ph1)
  • Histologically documented diagnosis of SCLC.(Ph2a)
  • At least one prior chemotherapy treatment regimen(s) and their disease is refractory or experienced progressive disease following the treatment. (Ph1)
  • Extensive-stage SCLC & is chemotherapy naïve(US only) has experienced progressive disease following at least one chemotherapy regimen or their disease is refractory.(Ph2a)
  • Brain metastases with clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function & no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug.
  • ECOG performance score <= 2(Ph 1) <=1(Ph 2a)
  • Must be receiving a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants (e.g. Prozac)21 days prior to 1st dose of study drug.
  • Adequate bone marrow, renal & hepatic function per local lab reference range at Screening as follows:

    • Bone marrow: Absolute Neutrophil count (ANC)>=1000/µL
    • Platelets>= 100,000/mm3
    • Hemoglobin>=9.0g/dL
    • Renal function: Serum creatinine<= 2.0mg/dL or calculated creatinine clearance>=50mL/min
    • Hepatic function&enzymes: AST and ALT<=3.0 x the upper normal limit(ULN) of institution's normal range
    • Bilirubin<=1.5xULN. If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
    • Coagulation: aPTT and PT<=1.2 x the upper limit of normal
  • Should have archived diagnostic tissue available for assessment of Bcl-2 family protein expression.(Pha 2a)
  • Surgically sterile postmenopausal(for at least one year) or a negative pregnancy test performed as follows:

    • At Screening on a serum sample obtained within 14 days prior to initial study drug administration, and
    • Prior to dosing on a urine sample obtained on Cycle 1 Day-3.
  • All female subjects not surgically sterile or postmenopausal(for at least 1 year)and non-vasectomized male subject must practice at least one of the following methods for birth control:

    • Total abstinence from sexual intercourse (minimum one complete menstrual cycle)
    • A vasectomized partner; hormonal contraceptives (oral, parenteral or transdermal) for at least three months prior to study drug administration
    • Double-barrier method(including condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
  • Subject, or legal representative voluntarily sign & date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

  • Underlying or predisposing condition of bleeding or currently exhibits signs of bleeding. Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug.
  • Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
  • History of platelet autoantibodies or autoimmune phenomena including immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA).
  • Currently receiving or requires anticoagulation therapy or any drug or herbal supplements that affect platelet function, with exception of low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter.
  • Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement or erythropoietin), or any investigational therapy within 14 days prior to the first dose of study drug, or has not recovered to less than a grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
  • Has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
  • Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. Questions regarding inclusion of individual subjects should be directed to Abbott Medical Monitor or designee.
  • Pregnant or breast-feeding.
  • Positive for HIV (due to potential drug-drug interactions and potential effects on lymphocytes).
  • Previous or current malignancies at other sites, with the exception of:

    • Adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin
    • Previous malignancy (e.g. localized prostate cancer)confined and surgically resected with no evidence of disease within three years.
  • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

    • Active systemic fungal infection
  • Diagnosis of fever and neutropenia within 1 week prior to study drug administration.
  • Subject received aspirin within seven days prior to the first dose of study drug.
  • Subject received steroid therapy within seven days prior to the first dose of study drug with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445198

Contacts
Contact: Cathy Nolan 847-937-2404 cathy.nolan@abbott.com

Locations
United States, Arizona
Dedicated Phase I Completed
Phoenix, Arizona, United States, 85013
United States, California
UC Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Grace Loredo     916-843-7133     grace.loredo@ucdmc.ucdavis.edu    
Principal Investigator: David R Gandara, MD            
United States, Colorado
University of Colorado Cancer Centre Recruiting
Aurora, Colorado, United States, 80045
Contact: DeLee Peake     303-724-1659     delee.peake@uchsc.edu    
Principal Investigator: Ross Camidge, MD            
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Deborah Pach     312-563-3347     deborah_b_pach@rush.edu    
Principal Investigator: Philip D. Bonomi,, MD, MS            
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21231
Contact: Susan Markus     443-287-2911     smarkus@jhmi.edu    
Principal Investigator: Charles M Rudin, MD, PhD            
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sara Thiede     617-632-5955     sthiede@dfci.harvard.edu    
Principal Investigator: Geoffry Shapiro, MD            
United States, Washington
Northwest Medical Specialties, PLLC Recruiting
Tacoma, Washington, United States, 98407
Contact: Julie Skarsvog     253-396-5329     jskarsvog@nwmsonline.com    
Principal Investigator: Moacyr Ribeiro de Oliveira, MD            
United Kingdom
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Abbott
Genentech
Investigators
Study Director: Global Medical Information (1-800-633-9110) Abbott
  More Information

Responsible Party: Abbott ( Diane Medina )
Study ID Numbers: M06-822
Study First Received: March 6, 2007
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00445198  
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
SCLC

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009