Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT00716534 | Completed Phase 2

• 2 other identifiers: M10-3012007-007107-32
• Study Type: interventional
• Target: 145
• Locations: 6 countries
• Sites: 37

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.

Conditions

Advanced or Metastatic Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Disease Progression

Secondary Outcomes (2)

• Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response

  Disease Progression

• Survival Rate

  12 Months

Study Arms (3)

A

EXPERIMENTAL

12.5 mg ABT-869 + Carboplatin/Paclitaxel

Drug: ABT-869; Drug: Carboplatin; Drug: Paclitaxel

B

EXPERIMENTAL

7.5 mg ABT-869 + Carboplatin/Paclitaxel

Drug: ABT-869; Drug: Carboplatin; Drug: Paclitaxel

C

PLACEBO COMPARATOR

Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel

Drug: Placebo for ABT-869; Drug: Carboplatin; Drug: Paclitaxel

Interventions

ABT-869 DRUG

12.5 mg ABT-869

A

Placebo for ABT-869 DRUG

Placebo Comparator (12.5 mg or 7.5 mg)

Also known as: Placebo

C

Carboplatin DRUG

Carboplatin (AUC 6 mg/mL/min)

A; B; C

Paclitaxel DRUG

Paclitaxel (200 mg/m2)

A; B; C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Genentech, Inc.: collaborator

Study Sites (37)

Site Reference ID/Investigator# 15850

Chandler, Arizona, 85224, United States

Location

Site Reference ID/Investigator# 15846

Peoria, Arizona, 85381, United States

Location

Site Reference ID/Investigator# 15841

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 7179

Atlanta, Georgia, 30322, United States

Location

Site Reference ID/Investigator# 15851

Lansing, Michigan, 48912, United States

Location

Site Reference ID/Investigator# 15844

Lebanon, New Hampshire, 03756, United States

Location

Site Reference ID/Investigator# 22443

Hackensack, New Jersey, 07601, United States

Location

Site Reference ID/Investigator# 15848

Greensboro, North Carolina, 27403, United States

Location

Site Reference ID/Investigator# 22444

Canton, Ohio, 44718, United States

Location

Site Reference ID/Investigator# 15847

Cleveland, Ohio, 44195, United States

Location

Site Reference ID/Investigator# 26842

Hershey, Pennsylvania, 17033-0850, United States

Location

Site Reference ID/Investigator# 13101

Philadelphia, Pennsylvania, 19106, United States

Location

Site Reference ID/Investigator# 24122

Philadelphia, Pennsylvania, 19107, United States

Location

Site Reference ID/Investigator# 19042

Bedford Park, 5042, Australia

Location

Site Reference ID/Investigator# 23682

Cairns, 4870, Australia

Location

Site Reference ID/Investigator# 21862

Lismore, 2480, Australia

Location

Site Reference ID/Investigator# 19043

Woodville South, 5011, Australia

Location

Site Reference ID/Investigator# 17703

Jaú, 17210-120, Brazil

Location

Site Reference ID/Investigator# 23522

Porto Alegre, 90050-170, Brazil

Location

Site Reference ID/Investigator# 15601

Porto Alegre, 90610-000, Brazil

Location

Site Reference ID/Investigator# 17704

Rio de Janeiro, 20231-050, Brazil

Location

Site Reference ID/Investigator# 22684

Santo André, 09060-650, Brazil

Location

Site Reference ID/Investigator# 17702

São Paulo, 01224-010, Brazil

Location

Site Reference ID/Investigator# 23582

São Paulo, 04024-002, Brazil

Location

Site Reference ID/Investigator# 18964

Kyjov, 69733, Czechia

Location

Site Reference ID/Investigator# 22504

Náchod, 54769, Czechia

Location

Site Reference ID/Investigator# 18963

Olomouc, 77520, Czechia

Location

Site Reference ID/Investigator# 18962

Prague, 12808, Czechia

Location

Site Reference ID/Investigator# 19022

Pribram V, 26995, Czechia

Location

Site Reference ID/Investigator# 38003

Kazan', 420029, Russia

Location

Site Reference ID/Investigator# 38260

Kirov, 610021, Russia

Location

Site Reference ID/Investigator# 18064

Moscow, 115478, Russia

Location

Site Reference ID/Investigator# 18065

Moscow, 115478, Russia

Location

Site Reference ID/Investigator# 23312

Moscow, 115478, Russia

Location

Site Reference ID/Investigator# 18066

Moscow, 143423, Russia

Location

Site Reference ID/Investigator# 23562

Saint Petersburg, 198255, Russia

Location

Site Reference ID/Investigator# 18961

Singapore, 119228, Singapore

Location

Related Publications (1)

• 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.

  PMID: 25559798 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

linifanib; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Justin L. Ricker, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (13); BR (7); CZ (5); AU (4); SG (1); RU (7)