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Lymphoid MalignancyPhase 1NCT00982566

Assess the Oral Bioavailability of a New ABT-263 Formulation in Subjects With Cancer

A Phase 1 study testing ABT-263 in people with Lymphoid Malignancy and Solid Tumors, run by AbbVie.

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 randomized, single dose, open-label, multicenter crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoid Malignancy, Solid Tumors
What is being tested?
ABT-263
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
No sites listed yet
Study dates
Oct 2009to Dec 2010
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 >= 18 years of age.
  • Subject has a lymphoid malignancy (histologic or cytologic confirmation), or solid tumor (radiographic, histologic, or cytologic confirmation) that is either:
  • relapsed or refractory to standard therapy, or
  • no known effective therapy exists.
  • In the investigator's opinion, the subject's life expectancy is at least 90 days.
  • Subjects with known 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 21 days prior to the first dose of study drug.
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  • If clinically indicated, subjects must have documented brain imaging (MRI or CT) negative for subdural or epidural hematoma within 28 days prior to the first dose of study drug.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of <= 2.
  • Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
  • Bone marrow: Absolute Neutrophil count (ANC) >= 1,000/µL; Platelets >= 100,000/mm3 (independent of platelet transfusions within 3 months prior to starting study drug); Hemoglobin >= 9.0 g/dL;
  • Renal function: serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min;
  • Hepatic function and enzymes: AST and ALT <= 2.5 x the upper normal limit (ULN) of institution's normal range; Bilirubin <= 1.5 x ULN. Subjects with Gilbert's Syndrome may have a Bilirubin > 1.5 x ULN; Subjects with liver metastasis may have an AST and ALT of <= 5.0 x ULN;
  • Coagulation: aPTT, PT not to exceed 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 on a serum sample obtained within 14 days prior to initial study drug administration, and
  • Prior to start of dosing on a urine sample if it has been > 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 prior to starting study drug);
  • 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 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

  • Subject has undergone an allogeneic stem cell transplant.
  • Subject has an underlying condition predisposing them to bleeding or currently exhibits signs of clinically significant bleeding.
  • Subject has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding within one year prior to the first dose of study drug.
  • Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  • Subject has a 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 the Abbott Medical Monitor or designee.
  • Female subject is pregnant or breast-feeding.
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  • Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, etc.).
  • Subject has tested positive for HIV (due to potential drug-drug interactions between anti retroviral inhibitors and ABT-263, as well as anticipated ABT-263 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections and potential drug-drug interactions with certain anti infective agents).
  • Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
  • active systemic fungal infection;
  • diagnosis of fever and neutropenia within one week prior to study drug administration.
  • Subject has received any of the following anti-cancer therapies 14 days prior to the first dose of study drug, or has not recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapies:
  • chemotherapy, immunotherapy, radiotherapy;
  • hormonal therapy (with the exception of hormones for hypothyroidism or estrogen replacement therapy [ERT], or agonists required to suppress serum testosterone levels [e.g., LHRH, GnRH, etc.] for subjects with prostate cancer if on a stable dose for 21 days prior to the first dose of study drug);
  • any investigational therapy, including targeted small molecule agents
  • Subject has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
  • 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, such as heparin, that are used to maintain the patency of a central intravenous catheter. Note, warfarin is excluded at any dose level.
  • Subject has received aspirin within 7 days prior to the first dose of study drug and during ABT-263 administration.
  • Subject has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
  • In the opinion of the investigator, the subject is an unsuitable candidate to receive ABT-263.
  • Subject has received a CYP3A inducer within 7 days prior to the first dose of study drug and during ABT-263 administration.

About this study

Official title: A Phase 1 Study Evaluating the Relative Oral Bioavailability of New Formulations of ABT-263 in Subjects With Cancer

This is a randomized, single dose, open-label, multicenter crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 48 evaluable subjects with lymphoid malignancies, including chronic lymphocytic leukemia, and solid tumors will be enrolled in this study.

Read the detailed description

Subjects who complete Part 1 of the study will be provided an opportunity to receive Formulation A under a continuous once daily dosing schedule during Part 2 of the study. Subjects enrolled in the second part of the study may continue to receive Formulation A under the continuous once daily dosing schedule for up to one year following the date of the last subject enrolled on study provided they continue to tolerate the drug, have no evidence of disease progression, and do not meet any of the protocol specific criteria for subject discontinuation.

Being tested
ABT-263

What participants receive

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

  • ABT-263Drug

    Part 1: Single (oral) dose of 250 mg of Formulation B1 vs. single (oral) dose of 250 mg of Formulation A

  • ABT-263Drug

    Part 1 continued. Single (oral) dose of 250 mg of Formulation B2 vs. single (oral) dose of 250 mg of Formulation A

  • ABT-263Drug

    Part 1: Single (oral) dose of 200 mg of Formulation C vs. single (oral) dose of 200 mg of Formulation A

  • ABT-263Drug

    Part 1: Single (oral) dose of 200 mg of Formulation C vs. single (oral) dose of 200 mg of Formulation A

Study groups in NCT00982566
Study groupRoleWhat they receive
Sequence IExperimentalNot described
Receives: Drug: ABT-263
Sequence IIExperimentalNot described
Receives: Drug: ABT-263
Sequence IIIExperimentalNot described
Receives: Drug: ABT-263
Sequence IVExperimentalNot described
Receives: Drug: ABT-263
Sequence VExperimentalNot described
Receives: Drug: ABT-263
Sequence VIExperimentalNot described
Receives: Drug: ABT-263
Sequence VIIExperimentalNot described
Receives: Drug: ABT-263
Sequence VIIIExperimentalNot described
Receives: Drug: ABT-263
Sequence IXExperimentalNot described
Receives: Drug: ABT-263
Sequence XExperimentalNot described
Receives: Drug: ABT-263
Sequence XIExperimentalNot described
Receives: Drug: ABT-263
Sequence XIIExperimentalNot described
Receives: Drug: ABT-263
Sequence XIIIExperimentalNot described
Receives: Drug: ABT-263
Sequence XIVExperimentalNot described
Receives: Drug: ABT-263
Sequence XVIExperimentalNot described
Receives: Drug: ABT-263
Sequence XVExperimentalNot described
Receives: Drug: ABT-263

What is being measured

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

  1. Assessment of Oral Bioavailability

    Assess the oral bioavailability of Formulation B1, Formulation B2, Formulation C, and Formulation D relative to that of Formulation A being assessed in ongoing Phase 1/2a ABT-263 studies

    Measured: Two Period and Three Period crossover design

Secondary outcomes (1)

  1. Adverse Events Tabulation

    Safety measures include number and percentage of subjects having treatment-emergent adverse events tabulated by MedDRA system organ class and preferred term, laboratory test results, lymphocyte enumeration results, vital signs, etc.

    Measured: Two Period and Three Period crossover design

Timeline

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

  1. First posted23 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionOct 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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00982566
Sponsor's protocol ID
M11-069
Status last verified
Jan 2011
First submitted
22 Sep 2009
Last updated
21 Nov 2017
Results posted
No

Publications

  • Xiong H, Pradhan RS, Nada A, Krivoshik AP, Holen KD, Rhodes JW, Gordon GB, Humerickhouse R, Awni WM. Studying navitoclax, a targeted anticancer drug, in healthy volunteers--ethical considerations and risk/benefit assessments and management. Anticancer Res. 2014 Jul;34(7):3739-46.

    PubMed 24982396

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-263 in people with Lymphoid Malignancy and Solid Tumors, run by AbbVie.

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 22 inclusion and 21 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Assessment of Oral Bioavailability (time frame: Two Period and Three Period crossover design). 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 NCT00982566, 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 21 Nov 2017.

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