A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00445198
First received: March 6, 2007
Last updated: January 17, 2013
Last verified: January 2013
  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. (This portion of the study is complete). 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
Small Cell Lung Carcinoma
Drug: ABT-263
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Small Cell Lung Cancer or Other Non-Hematological Malignancies

Resource links provided by NLM:


Further study details as provided by AbbVie:

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

Enrollment: 86
Study Start Date: April 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 and Phase 2a Drug: ABT-263

Phase 1 dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing.

- 50 patients with SCLC and non-hematologic malignancies. Enrollment is closed in this arm of the study.

Phase 2a dosing under two different schedules: 14 days on drug, 7 days off or continuous dosing.

- 40 patients with SCLC


  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 and/or cytologically documented diagnosis of small cell lung cancer (North America & UK) or other non-hematological malignancy (North America only).(Phase 1 only)
  • Histologically and/or cytologically documented diagnosis of SCLC.(Phase 2a)
  • At least one prior chemotherapy treatment regimen(s) and their disease is refractory or experienced progressive disease following the treatment.(Phase 1)
  • Extensive-stage SCLC & is chemotherapy naïve(US only) has experienced progressive disease following at least one chemotherapy regimen or their disease is refractory.(Phase 2a)
  • 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(Phase 2a)
  • Must be receiving a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants 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.(Phase 2a)
  • All female subjects not surgically sterile or postmenopausal(for at least 1 year)and non-vasectomized male subject must practice at least one method of birth control.

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.
  • The subject has active immune thrombocytopenic purpura (ITP),active autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
  • 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 therapy (ERT), anti estrogen analogs, agonists required to suppress serum testosterone levels), 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 adverse effect(s) of the previous therapy.
  • Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug.
  • Steroid therapy for anti-neoplastic intent within seven days prior to the first dose of study drug.
  • Has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
  • Significant history of cardiovascular disease, 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.
  • Positive for HIV
  • A history of other active malignancies within the past 3 years prior to screening, 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
  • 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.
  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: NCT00445198

Locations
United States, Arizona
Site Reference ID/Investigator# 13605
Peoria, Arizona, United States, 85381
Site Reference ID/Investigator# 5261
Phoenix, Arizona, United States, 85013
United States, California
Site Reference ID/Investigator# 11942
Los Angeles, California, United States, 90095-7187
Site Reference ID/Investigator# 4718
Sacramento, California, United States, 95817
United States, Colorado
Site Reference ID/Investigator# 3755
Aurora, Colorado, United States, 80045-0510
United States, Georgia
Site Reference ID/Investigator# 8324
Atlanta, Georgia, United States, 30322
United States, Illinois
Site Reference ID/Investigator# 2623
Chicago, Illinois, United States, 60612
United States, Maryland
Site Reference ID/Investigator# 2625
Baltimore, Maryland, United States, 21231-1000
Site Reference ID/Investigator# 12343
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Site Reference ID/Investigator# 2626
Boston, Massachusetts, United States, 02215
Site Reference ID/Investigator# 11941
Boston, Massachusetts, United States, 02215
United States, North Carolina
Site Reference ID/Investigator# 4934
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Site Reference ID/Investigator# 2624
Nashville, Tennessee, United States, 37203
United States, Washington
Site Reference ID/Investigator# 6650
Tacoma, Washington, United States, 98405
Canada
Site Reference ID/Investigator# 7493
Edmonton, Canada, T6G 1Z2
Site Reference ID/Investigator# 7635
Ottawa, Canada, K1H 8L6
United Kingdom
Site Reference ID/Investigator# 18541
Leicester, United Kingdom, LE1 5WW
Site Reference ID/Investigator# 2622
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00445198     History of Changes
Obsolete Identifiers: NCT00929513
Other Study ID Numbers: M06-822, 2006-003298-28
Study First Received: March 6, 2007
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
SCLC

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Navitoclax
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014