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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00716534




Registration number
NCT00716534
Ethics application status
Date submitted
14/07/2008
Date registered
16/07/2008
Date last updated
29/04/2013

Titles & IDs
Public title
Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
Secondary ID [1] 0 0
2007-007107-32
Secondary ID [2] 0 0
M10-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-869
Treatment: Drugs - Placebo for ABT-869
Treatment: Drugs - ABT-869
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel

Experimental: A - 12.5 mg ABT-869 + Carboplatin/Paclitaxel

Experimental: B - 7.5 mg ABT-869 + Carboplatin/Paclitaxel

Placebo comparator: C - Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel


Treatment: Drugs: ABT-869
12.5 mg ABT-869

Treatment: Drugs: Placebo for ABT-869
Placebo Comparator (12.5 mg or 7.5 mg)

Treatment: Drugs: ABT-869
7.5 mg ABT-869

Treatment: Drugs: Carboplatin
Carboplatin (AUC 6 mg/mL/min)

Treatment: Drugs: Paclitaxel
Paclitaxel (200 mg/m2)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Disease Progression
Secondary outcome [1] 0 0
Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response
Timepoint [1] 0 0
Disease Progression
Secondary outcome [2] 0 0
Survival Rate
Timepoint [2] 0 0
12 Months

Eligibility
Key inclusion criteria
* Subject must be at least 18 years of age.
* Subject must have cytologically or histologically confirmed non-squamous NSCLC
* Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
* Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
* Subject has an ECOG Performance Score of 0-1.
* Willing to take adequate measures to prevent pregnancy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The subject has NSCLC with a predominant squamous cell histology
* Subject has hypersensitivity to paclitaxel.
* Subject has received any anti-cancer therapy for treatment of NSCLC.
* Subject has received radiation therapy within 21 days of Study Day 1.
* Subject has had major surgery within 21 days.
* Subject has untreated brain or meningeal metastases.
* Subject is receiving therapeutic anticoagulation therapy.
* Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
* Subject has proteinuria CTC Grade > 1 at baseline.
* Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg.
* The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.
* The subject has a documented left ventricular (LV) ejection fraction < 50%.
* The subject has known autoimmune disease with renal involvement (i.e., lupus).
* The subject is receiving combination anti-retroviral therapy for HIV.
* The subject has clinically significant uncontrolled condition(s).
* The subject has a history of another active cancer within the past 5 years.
* The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
* The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
* The subject is pregnant or breast feeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 19042 - Bedford Park
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 23682 - Cairns
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 21862 - Lismore
Recruitment hospital [4] 0 0
Site Reference ID/Investigator# 19043 - Woodville South
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
Brazil
State/province [10] 0 0
Jau
Country [11] 0 0
Brazil
State/province [11] 0 0
Porto Alegre
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio de Janeiro
Country [13] 0 0
Brazil
State/province [13] 0 0
Santo Andre
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Kyjov
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Nachod
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Olomouc
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Prague 2
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Pribram V
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Kazan
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Kirov
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Moscow
Country [23] 0 0
Russian Federation
State/province [23] 0 0
St. Petersburg
Country [24] 0 0
Singapore
State/province [24] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.
Trial website
https://clinicaltrials.gov/study/NCT00716534
Trial related presentations / publications
Ramalingam SS, Shtivelband M, Soo RA, Barrios CH, Makhson A, Segalla JG, Pittman KB, Kolman P, Pereira JR, Srkalovic G, Belani CP, Axelrod R, Owonikoko TK, Qin Q, Qian J, McKeegan EM, Devanarayan V, McKee MD, Ricker JL, Carlson DM, Gorbunova VA. Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2015 Feb 10;33(5):433-41. doi: 10.1200/JCO.2014.55.7173. Epub 2015 Jan 5.
Public notes

Contacts
Principal investigator
Name 0 0
Justin L. Ricker, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00716534