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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoid Malignancies, Solid Tumors

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Trial Information

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


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.


Inclusion Criteria:



1. Subject must be >= 18 years of age.

2. 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.

3. In the investigator's opinion, the subject's life expectancy is at least 90 days.

4. 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.

5. 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.

6. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of <= 2.

7. 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/┬ÁL; 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.

8. 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.

9. 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).

10. 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.

Exclusion Criteria:

1. Subject has undergone an allogeneic stem cell transplant.

2. Subject has an underlying condition predisposing them to bleeding or currently
exhibits signs of clinically significant bleeding.

3. Subject has a recent history of non-chemotherapy induced thrombocytopenic associated
bleeding within one year prior to the first dose of study drug.

4. Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.

5. 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.

6. Female subject is pregnant or breast-feeding.

7. 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.).

8. 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).

9. 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.

10. 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

11. Subject has received a biologic agent for anti-neoplastic intent within 30 days prior
to the first dose of study drug.

12. 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.

13. Subject has received aspirin within 7 days prior to the first dose of study drug and
during ABT-263 administration.

14. Subject has consumed grapefruit or grapefruit products within 3 days prior to the
first dose of study drug.

15. In the opinion of the investigator, the subject is an unsuitable candidate to receive
ABT-263.

16. Subject has received a CYP3A inducer within 7 days prior to the first dose of study
drug and during ABT-263 administration.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of Oral Bioavailability

Outcome Description:

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

Outcome Time Frame:

Two Period and Three Period crossover design

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

M11-069

NCT ID:

NCT00982566

Start Date:

October 2009

Completion Date:

December 2010

Related Keywords:

  • Lymphoid Malignancies
  • Solid Tumors
  • Neoplasms

Name

Location

Site Reference ID/Investigator# 22542 Indianapolis, Indiana  46202
Site Reference ID/Investigator# 35882 Detroit, Michigan  48201
Site Reference ID/Investigator# 20863 San Antonio, Texas  78229