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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/NCT00716534
Trial related presentations / publications
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/ct2/show/NCT00716534