AzTrials
AzTrials

Small Cell Lung CancerPhase 1/2NCT00445198

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

A Phase 1/2 study testing ABT-263 in people with Small Cell Lung Cancer and Small Cell Lung Carcinoma, run by AbbVie (prior sponsor, Abbott) at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABT-263
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
18 sitesin 3 countries
Study dates
Apr 2007to Dec 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 18Show fewer
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

United States14 sites

  • Site Reference ID/Investigator# 8324

    Atlanta, Georgia, 30322

  • Site Reference ID/Investigator# 3755

    Aurora, Colorado, 80045-0510

  • Site Reference ID/Investigator# 2625

    Baltimore, Maryland, 21231-1000

  • Site Reference ID/Investigator# 12343

    Bethesda, Maryland, 20892

  • Site Reference ID/Investigator# 11941

    Boston, Massachusetts, 02215

  • Site Reference ID/Investigator# 2626

    Boston, Massachusetts, 02215

  • Site Reference ID/Investigator# 4934

    Charlotte, North Carolina, 28204

  • Site Reference ID/Investigator# 2623

    Chicago, Illinois, 60612

  • Site Reference ID/Investigator# 11942

    Los Angeles, California, 90095-7187

  • Site Reference ID/Investigator# 2624

    Nashville, Tennessee, 37203

  • Site Reference ID/Investigator# 13605

    Peoria, Arizona, 85381

  • Site Reference ID/Investigator# 5261

    Phoenix, Arizona, 85013

  • Site Reference ID/Investigator# 4718

    Sacramento, California, 95817

  • Site Reference ID/Investigator# 6650

    Tacoma, Washington, 98405

Other trials in United States

Canada2 sites

  • Site Reference ID/Investigator# 7493

    Edmonton, T6G 1Z2

  • Site Reference ID/Investigator# 7635

    Ottawa, K1H 8L6

Other trials in Canada

United Kingdom2 sites

  • Site Reference ID/Investigator# 18541

    Leicester, LE1 5WW

  • Site Reference ID/Investigator# 2622

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

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

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.

Being tested
ABT-263
Keywords
SCLC
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-263Drug

    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
Study groups in NCT00445198
Study groupRoleWhat they receive
Phase 1 and Phase 2aExperimentalNot described
Receives: Drug: ABT-263

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety assessment

    Measured: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing

  2. Dose limiting toxicity determination

    Measured: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing

  3. Maximum tolerated dose determination

    Measured: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing

  4. Pharmacokinetic profile evaluation

    Measured: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing

Secondary outcomes (2)

  1. Extended safety assessment at the recommended Phase 2 dose

    Measured: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing

  2. Preliminary efficacy assessment

    Measured: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00445198
Sponsor's protocol ID
M06-822
Other IDs
2006-003298-28
Status last verified
Jan 2013
First submitted
6 Mar 2007
Last updated
6 Jun 2018
Results posted
No

Publications

  • Gandhi L, Camidge DR, Ribeiro de Oliveira M, Bonomi P, Gandara D, Khaira D, Hann CL, McKeegan EM, Litvinovich E, Hemken PM, Dive C, Enschede SH, Nolan C, Chiu YL, Busman T, Xiong H, Krivoshik AP, Humerickhouse R, Shapiro GI, Rudin CM. Phase I study of Navitoclax (ABT-263), a novel Bcl-2 family inhibitor, in patients with small-cell lung cancer and other solid tumors. J Clin Oncol. 2011 Mar 1;29(7):909-16. doi: 10.1200/JCO.2010.31.6208. Epub 2011 Jan 31.

    PubMed 21282543

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABT-263 in people with Small Cell Lung Cancer and Small Cell Lung Carcinoma, run by AbbVie (prior sponsor, Abbott) at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety assessment (time frame: Repeating sequence of 14 days on therapy and 7 days off or continuous dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00445198, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in