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A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer


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

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Trial Information

A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer


Inclusion Criteria:



- Must be greater then or equal to18 years of age;

- For dose escalation subject must have histologically and/or cytologically documented
cancer for which etoposide/cisplatin has been determined to be an appropriate
therapy. For expanded safety cohort subject must have histologically and/or
cytologically documented SCLC for which etoposide/cisplatin has been determined an
appropriate therapy;

- Subject has an ECOG performance score of less then or equal to 1; Evaluable and/or
measurable disease by CT or MRI per RECIST criteria;

- 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 21 days prior to the 1st dose of study drug;

- Must have adequate renal and hepatic function, per local laboratory reference range
at Screening as follows:

- ANC greater then or equal to 1500/mcL,

- Platelets greater then or equal to 150,000/mm^3,

- Hemoglobin greater then or equal to 10.0 g/dL,

- Serum creatinine less then or equal to 1.5 mg/dL or calculated creatinine
clearance greater then or equal to 50 mL/min; Na greater then 130 mmol/L,

- Alkaline Phosphatase, AST and ALTless then or equal to 2.5 x ULN ;Bilirubin less
then or equal to 1.5 x ULN.Subjects with liver mets may have ALP, AST and ALT
less then or equal to 5.0 x ULN, Subjects with bone mets may have Alkaline
Phosphatase less then or equal to 5.0 x ULN,

- Subjects with Gilbert's Syndrome may have a Bilirubin greater then 1.5 x ULN,

- Coagulation: aPTT, PT, less then or equal to 1.2 x ULN;

- Life expectancy of at least 30 days;

- 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 one year) and
non-vasectomized male subjects must practice at least one method of birth control.

Exclusion Criteria:

- Subject exhibits evidence of other uncontrolled condition(s) including, but not
limited to: active systemic infection, diagnosis of fever or neutropenia within 1
week of 1st dose;

- Subject has an underlying, predisposing condition of bleeding or currently exhibits
signs of bleeding;

- Subject is currently receiving or requires anticoagulation therapy;

- Subject has active immune thrombocytopenic purpura, autoimmune hemolytic anemia or a
history of being refractory to platelet transfusions (within 1 year prior to 1st dose
of study drug);

- Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis;

- Subject has a significant history of CV disease, renal, neurologic, psychiatric,
endocrinologic, metabolic, immunologic, or hepatic disease;

- Female subject is pregnant or breast-feeding;

- Subject has tested positive for HIV;

- Subject has a history of other active malignancies within 3 years prior to study
entry, 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;

- Subject has received any anti-cancer therapy within 14 days prior to 1st dose of
study drug;

- Subject has received steroid therapy for anti-neoplastic intent within 7 days prior
to 1st dose of study drug;

- Subject has received aspirin within 7 days prior to 1st dose of study drug;

- Subject has received radio-immunotherapy within 6 months prior to 1st dose of study
drug; Subject has received an antibody therapy or other biologics (with the exception
of colony stimulating factors [G-CSF,GM-CSF] or erythropoietin) within 28 days prior
to 1st dose of study drug;

- Subject has a hypersensitivity to platinum-containing compounds or etoposide;

- Subject has consumed grapefruit within 3 days prior to 1st dose of study drug.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety profile of ABT-263 when administered in combination with etoposide/cisplatin in subjects with Cancer.

Outcome Time Frame:

Weekly

Safety Issue:

Yes

Principal Investigator

Mack Mabry, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M10-234

NCT ID:

NCT00878449

Start Date:

October 2009

Completion Date:

July 2011

Related Keywords:

  • Solid Tumors

Name

Location

Site Reference ID/Investigator# 13323Chicago, Illinois  60637
Site Reference ID/Investigator# 12841Maywood, Illinois  60153
Site Reference ID/Investigator# 12303Baltimore, Maryland  21231
Site Reference ID/Investigator# 12305Boston, Massachusetts  02215
Site Reference ID/Investigator# 20381Boston, Massachusetts  02215
Site Reference ID/Investigator# 43505Detroit, Michigan  48202
Site Reference ID/Investigator# 13322New Brunswick, New Jersey  08901