Clinical trial NCT00878449: A Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer
Official title: A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2009-04-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC).


Eligibility criteria: 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.

Primary outcomes:
measure: Assess the safety profile of ABT-263 when administered in combination with etoposide/cisplatin in subjects with Cancer.
timeFrame: Weekly
measure: Characterize the pharmacokinetics of ABT-263 when administered in combination with etoposide/cisplatin .
timeFrame: Weekly
measure: Determine the maximum tolerable dose (MTD) of ABT-263 when administered in combination with etoposide/cisplatin.
timeFrame: Weekly
measure: Determine the recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with etoposide/cisplatin.
timeFrame: Weekly
Secondary outcomes:
measure: Evaluate preliminary data regarding progression free survival (PFS).
timeFrame: Bi-monthly
measure: Evaluate preliminary data regarding objective response rate (ORR).
timeFrame: Bi-monthly
measure: Evaluate preliminary data regarding time to tumor progression (TTP).
timeFrame: Bi-monthly
measure: Evaluate preliminary data regarding overall survival (OS).
timeFrame: Bi-monthly
measure: Evaluate preliminary data regarding duration of overall response.
timeFrame: Bi-monthly
measure: Evaluate preliminary data regarding Eastern Cooperative Oncology Group (ECOG) performance status.
timeFrame: Bi-monthly
measure: Evaluate biomarkers
timeFrame: Bi-monthly
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 13323
state: Illinois
city: Maywood
country: United States
facility: Site Reference ID/Investigator# 12841
state: Illinois
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 12303
state: Maryland
city: Boston
country: United States
facility: Site Reference ID/Investigator# 12305
state: Massachusetts
city: Boston
country: United States
facility: Site Reference ID/Investigator# 20381
state: Massachusetts
city: Detroit
country: United States
facility: Site Reference ID/Investigator# 43505
state: Michigan
city: New Brunswick
country: United States
facility: Site Reference ID/Investigator# 13322
state: New Jersey
Study officials:
affiliation: AbbVie
name: Mack Mabry, MD
role: STUDY_DIRECTOR
References:
citation: Pietanza MC, Rudin CM. Novel therapeutic approaches for small cell lung cancer: the future has arrived. Curr Probl Cancer. 2012 May-Jun;36(3):156-73. doi: 10.1016/j.currproblcancer.2012.03.005. Epub 2012 Apr 10. No abstract available.