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A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-263 in Combination With Erlotinib and ABT-263 in Combination With Irinotecan, and Evaluating the Safety of ABT-263 Monotherapy in Subjects With Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-263 in Combination With Erlotinib and ABT-263 in Combination With Irinotecan, and Evaluating the Safety of ABT-263 Monotherapy in Subjects With Cancer


Inclusion Criteria:



- Greater than or equal to 18 years of age.

- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to
2.

- Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or
have negative results for a pregnancy test.

- Female subjects not surgically sterile or postmenopausal (for at least 1 year) and
non vasectomized male subjects must practice at least one method of birth control.

- Arm A (ABT-263 and Erlotinib) and B (ABT-263 and Irinotecan) do not require prior
ABT-263 exposure, however, for Arm C (ABT-263 monotherapy), subjects must have
completed at least one dose of ABT-263 during a previous study.

- For Arm A (ABT-263 and Erlotinib) and Arm B (ABT-263 and Irinotecan), subjects should
have histologically and/or cytologically documented cancer for which irinotecan or
erlotinib has been determined to be an appropriate therapy as determined by the
Investigator.

- For Arm C (ABT 263 monotherapy), subject should have a malignancy that is either
relapsed or refractory to standard therapy or no known effective therapy exists.

- Adequate bone marrow, renal and hepatic function per local laboratory reference range
as follows: * Bone marrow: Absolute Neutrophil count (ANC) greater than or equal to
1,000/microliter; Platelets greater than or equal to 100,000/mm raised to the 3rd
power (Greater than or equal to 150,000/mm raised to the 3rd power for irinotecan
combination) independent of platelet transfusions within 3 months prior to starting
study drug; Hemoglobin greater than or equal to 9.0 grams/deciliter; * Renal
function: serum creatinine less than or equal to 2.0 milligrams/deciliter or
calculated creatinine clearance greater than or equal to 50 milliliter/minute; *
Hepatic function and enzymes: AST and ALT less than or equal to 3.0 multiplied by
the upper normal limit (ULN) of institution's normal range; Bilirubin less than or
equal to 1.5 multiplied by ULN. Subjects with Gilbert's Syndrome may have a
Bilirubin Greater than 1.5 multiplied by ULN; Subjects with liver metastasis may have
AST and ALT of less than or equal to 5.0 multiplied by the upper limit of normal; *
Coagulation: aPTT, PT not to exceed 1.2 multiplied by ULN.

- Subjects with neurologic symptoms (e.g., visual problems, headache, seizure) must
have documented brain imaging (MRI or CT) within 28 days prior to the first dose of
study drug. If imaging is performed, then subject should be negative for subdural or
epidural hematoma. Subjects with brain metastases must have clinically controlled
symptoms as 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 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:

- 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. Question
regarding inclusion of individual subjects should be directed to the Abbott Medical
Monitor or designee.

- Female subject is pregnant or breast-feeding.

- 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 conditions(s)
including, but not limited to: * active systemic fungal infection; * diagnosis of
fever and neutropenia within 1 week prior to study drug administration.

- Subject has received any of the following anti-cancer therapy 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 therapy: * chemotherapy,
immunotherapy, radiotherapy; * hormonal (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 other than ABT-263, 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 (e.g., warfarin at
any dose) 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 catheter.

- Subject has received aspirin or warfarin within 7 days prior to the first dose of
study drug.

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

- History of hypersensitivity to erlotinib or other polysorbate 80 drugs (not
applicable for ABT 263 monotherapy).

- Received potent CYP3A inhibitors (e.g., ketoconazole) within 7 days prior to the
first dose of study drug.

- Received ABT-263 within 3 days prior to the first dose of study drug (not applicable
to ABT-263 monotherapy).

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

- Subject has received rifampin within 4 days prior to first dose of study drug in Arm
A (ABT-263 and erlotinib) or Arm C (ABT-263 Monotherapy) and within 7 days prior to
first dose of study drug in Arm B (ABT-263 and irinotecan).

- Subjects who are UGT1A1*28 7/7 homozygous in Arm B (ABT-263 and irinotecan) of the
study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Arm A

Outcome Description:

• assess the safety profile of ABT-263 in combination with erlotinib; • study the pharmacokinetic interaction between ABT-263 and erlotinib; • determine the maximum tolerated dose (MTD) of ABT-263 when administered with erlotinib

Outcome Time Frame:

Weekly

Safety Issue:

Yes

Principal Investigator

Kyle Holen

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M11-958

NCT ID:

NCT01009073

Start Date:

October 2009

Completion Date:

June 2013

Related Keywords:

  • Solid Tumors

Name

Location

Site Reference ID/Investigator# 37463Santa Monica, California  90404
Site Reference ID/Investigator# 36342Detroit, Michigan  48201
Site Reference ID/Investigator# 24046San Antonio, Texas  78229
Site Reference ID/Investigator# 44917Tacoma, Washington  98405