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Solid TumorPhase 1NCT00888108

Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With Cancer

A Phase 1 study testing ABT-263 and Docetaxel in people with Solid Tumor, run by Abbott at 6 sites in 3 countries.

Completed

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

Official record
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Trial summary

This is a Phase 1 open-label study evaluating the safety of ABT-263 when combined with a standard and weekly regimen of docetaxel in subjects who have solid tumors with measurable disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
ABT-263 and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
6 sitesin 3 countries
Study dates
Jul 2009to Mar 2012
Phase
Phase 1
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

  • Subject must be greater then or equal to 18 years of age.
  • Subject must have a histologically and/or cytologically documented cancer for which docetaxel has been determined to be an appropriate therapy, per the Investigator.
  • Subject must have evaluable and/or measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as defined by RECIST.
  • 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 28 days prior to the first dose of study drug.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of less then or equal to 1.
  • Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
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  • Bone marrow: Absolute Neutrophil Count (ANC) greater then or equal to 1500/microliters; platelets greater then or equal to 150,000/mm^3; hemoglobin greater then or equal to 9.0 g/dL;
  • Renal function: Serum creatinine less then or equal 2.0 mg/dL or calculated creatinine clearance greater than or equal to 50 mL/min;
  • Hepatic function and enzymes: AST and ALT less then or equal to 1.5 x the upper limit of normal (ULN) of institution's normal range, ALP less then or equal to 2.5 x ULN, and bilirubin less then or equal to 1.0 x ULN. Subjects with bone metastasis may have ALP less then or equal to 5.0 x ULN.
  • Coagulation: aPTT and PT not to exceed less than or equal to 1.2 x ULN.
  • Female subjects must be surgically sterile, postmenopausal (for at least one year), or have negative results for a pregnancy test performed as follows:
  • At Screening via a serum sample obtained within 14 days prior to initial study drug administration, and
  • Prior to dosing via a urine sample obtained on Cycle 1 Day 1, if it has been greater then 7 days since obtaining the serum pregnancy test results.
  • Female subjects not surgically sterile or postmenopausal (for at least one year) and non-vasectomized male subjects must practice at least one of the following methods of birth control:
  • total abstinence from sexual intercourse (minimum one complete menstrual cycle);
  • 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).
  • The subject, or legal representative, must voluntarily sign and 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.

Who cannot join

  • The subject has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding. The subject has a recent history of thrombocytopenia associated with bleeding within 1 year prior to first dose of study drug.
  • The subject is currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications (i.e., Heparin) that are used to maintain the patency of a central intravenous catheter.
  • A female subject is pregnant or breast-feeding.
  • The subject has active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
  • The subject has active immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
  • The subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal therapy (with the exception of hormones for hypothyroidism, estrogen replacement therapy [ERT], anti estrogen analogs, agonists required to suppress serum testosterone levels [e.g., LHRH, GnRH, etc.] for subjects with prostate cancer if on a stable dose for at least 21 days prior to the first dose of study drug), or any investigational therapy with 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.
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  • The subject has received an antibody therapy or other biologic (with the exception of colony stimulating factors [G-CSF, GM-CSF] or erythropoietin) within 28 days prior to the first dose of study drug.
  • The subject has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
  • The subject has received steroid therapy for anti-neoplastic intent within 7 days prior to the first dose of study drug with the exception of inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication for this study.
  • The subject has received aspirin or known CYP3A inhibitor (e.g., ketoconazole) within 7 days prior to the first dose of study drug.
  • The subject has undergone an allogeneic stem cell transplant.
  • The subject has received radio-immunotherapy within 6 months prior to the first dose of study drug.
  • The subject has a history of hypersensitivity to docetaxel or other polysorbate 80 drugs.
  • The subject has tested positive for human immunodeficiency virus, HIV (due to potential drug-drug interactions between anti-retroviral medications and navitoclax (ABT-263), as well as anticipated navitoclax (ABT-263) mechanism based lymphopenia that may potentially increase the risk of opportunistic infections and potential drug-drug interactions with certain anti infective agents).
  • The subject has a significant history of cardiovascular (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 the Abbott Medical Monitor or designee.
  • The subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
  • active systemic fungal infection;
  • A diagnosis of fever and neutropenia within 1 week prior to study drug administration.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

United States3 sites

  • Site Reference ID/Investigator# 43962

    Baltimore, Maryland, 21231

  • Site Reference ID/Investigator# 44182

    Fort Lauderdale, Florida, 33308

  • Site Reference ID/Investigator# 51982

    Scottsdale, Arizona, 85258

Other trials in United States

Netherlands2 sites

  • Site Reference ID/Investigator# 12844

    Rotterdam, 3015 CE

  • Site Reference ID/Investigator# 20042

    Rotterdam, 3015 CE

Other trials in Netherlands

United Kingdom1 site

  • Site Reference ID/Investigator# 12845

    Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Taxotere® (Docetaxel) in the Treatment of Subjects With Solid Tumors

This is a Phase 1 open-label study evaluating the safety of ABT-263 when combined with a standard and weekly regimen of docetaxel in subjects who have solid tumors with measurable disease.

Conditions
Solid Tumor
Being tested
ABT-263, Docetaxel

What participants receive

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

  • ABT-263Drug

    150 mg of ABT-263 is taken orally once daily on Days 1-5 or Days 1-3 of each 21 day cycle. 150 mg of ABT-263 on Days 1-3, 8-10 and 15-17 of each 28-day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.

  • DocetaxelDrug

    Also called docetaxel, taxotere

    75 mg/m2 will be given by intravenous infusion on day 1 of each 21 -day cycle. 30 mg/m2 will be given by intravenous infusion on day 1, 8, 15 of each 28 -day cycle.

Study groups in NCT00888108
Study groupRoleWhat they receive
docetaxel +ABT-263ExperimentalNot described
Receives: Drug: ABT-263; Drug: Docetaxel

What is being measured

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

  1. Assess the safety profile of navitoclax (ABT-263) when administered in combination with a standard and weekly regimen of docetaxel.

    Measured: Weekly

  2. Study the pharmacokinetic interaction of navitoclax (ABT-263) and docetaxel

    Measured: Weekly

  3. Determine the maximum tolerated dose (MTD) of navitoclax (ABT-263) with a standard regimen of docetaxel

    Measured: Weekly

  4. Determine the MTD of both navitoclax and docetaxel with a weekly schedule.

    Measured: Weekly

Secondary outcomes (7)

  1. Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule in combination with a standard and weekly regimen of docetaxel.

    Measured: Bimonthly

  2. Evaluate preliminary data regarding progression free survival

    Measured: Bimonthly

  3. Evaluate preliminary data regarding objective response rate

    Measured: Bimonthly

  4. Evaluate preliminary data regarding overall survival

    Measured: Bimonthly

  5. Evaluate preliminary data regarding duration of overall response

    Measured: Bimonthly

  6. Evaluate preliminary data with Eastern Cooperative Oncology Group (ECOG) performance status

    Measured: Bimonthly

  7. Evaluate biomarkers

    Define the relationship between disease states, B-Cell Lymphoma 2 (Bcl-2) family protein expression, and potential response to the proposed therapy navitoclax when added to a standard and weekly regimen of docetaxel.

    Measured: Bimonthly

Timeline

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

  1. First posted24 Apr 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionMar 2012
  4. Study completionMar 2012

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00888108
Sponsor's protocol ID
M10-338
Other IDs
2008-001477-15, 2008
Status last verified
May 2012
First submitted
23 Apr 2009
Last updated
22 May 2012
Results posted
No

Publications

  • Puglisi M, Molife LR, de Jonge MJ, Khan KH, Doorn LV, Forster MD, Blanco M, Gutierrez M, Franklin C, Busman T, Yang J, Eskens FA. A Phase I study of the safety, pharmacokinetics and efficacy of navitoclax plus docetaxel in patients with advanced solid tumors. Future Oncol. 2021 Jul;17(21):2747-2758. doi: 10.2217/fon-2021-0140. Epub 2021 Apr 14.

    PubMed 33849298

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-263 and Docetaxel in people with Solid Tumor, run by Abbott at 6 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 19 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 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Netherlands, 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 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.

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?

Assess the safety profile of navitoclax (ABT-263) when administered in combination with a standard and weekly regimen of docetaxel. (time frame: Weekly). 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 NCT00888108, 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 22 May 2012.

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