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

June 1, 2018 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessment
Time Frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Dose limiting toxicity determination
Time Frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Maximum tolerated dose determination
Time Frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Pharmacokinetic profile evaluation
Time Frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Repeating sequence of 14 days on therapy and 7 days off or continuous dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Preliminary efficacy assessment
Time Frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing
Repeating sequence of 14 days on therapy and 7 days off or continuous dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 6, 2007

First Submitted That Met QC Criteria

March 6, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-822
  • 2006-003298-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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