NCT00320255

Brief Summary

The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

August 16, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

April 28, 2006

Results QC Date

March 14, 2016

Last Update Submit

August 11, 2016

Conditions

ThrombosisCancerPulmonary Embolism

Keywords

anticoagulant

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding

    Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following: * A decrease in hemoglobin of 20 g/L or more or * Required transfusion of 2 or more units of packed red blood cells or whole blood, or * Occurred in a critical site * Contributed to death. CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including: * Skin hematoma * Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention * Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract * Any other bleeding type that was considered to have clinical consequences.

    From first dose to 2 days following last dose of study drug

Secondary Outcomes (11)

  • Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death

    First dose to 2 days following last dose of study drug

  • Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death

    First dose to 30 days following last dose of study drug

  • Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death

    First dose to 2 days following last dose of study drug

  • Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death

    First dose to 2 days following last dose of study drug

  • Number of Participants With All-Cause Death

    First dose to 2 days following last dose of study drug

  • +6 more secondary outcomes

Study Arms (6)

Cohort 1: Placebo

PLACEBO COMPARATOR

Participants received placebo tablets once daily

Drug: Placebo

Cohort 1: Apixaban, 5 mg

PLACEBO COMPARATOR

Participants received apixaban as tablet, 5 mg, once daily

Drug: Apixaban

Cohort 1: Apixaban, 10 mg

ACTIVE COMPARATOR

Participants received apixaban as tablet, 10 mg, once daily

Drug: Apixaban

Cohort 1: Apixaban, 20 mg

ACTIVE COMPARATOR

Participants received apixaban as tablet, 20 mg, once daily

Drug: Apixaban

Cohort 2: Placebo

PLACEBO COMPARATOR

Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.

Drug: Placebo

Cohort 2: Apixaban, 5 mg

ACTIVE COMPARATOR

Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.

Drug: Apixaban

Interventions

ApixabanDRUG

Oral tablets administered once daily in 5-, 10-, or 20-mg dose

Also known as: BMS-562247
Cohort 1: Apixaban, 10 mgCohort 1: Apixaban, 20 mgCohort 1: Apixaban, 5 mgCohort 2: Apixaban, 5 mg
PlaceboDRUG

Oral tablets administered once daily

Cohort 1: PlaceboCohort 2: Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
  • Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
  • Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
  • Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law

You may not qualify if:

  • Women who are pregnant, breastfeeding
  • History of deep vein thrombosis or pulmonary embolism
  • Active bleeding or at high risk of bleeding
  • Metastatic brain cancer
  • Familial bleeding diathesis
  • Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry
  • Expected survival \<6 months or an Eastern Cooperative Oncology Group performance status ≥3.
  • Candidates for bone marrow transplantation within the 12-week treatment period or 30-day follow-up period
  • Uncontrolled hypertension (systolic blood pressure \>200 mm Hg and/or diastolic blood pressure \>110 mm Hg
  • Coagulopathy (international normalized ratio \>1.5 or platelet count \<100\*10\^9/L) if not yet receiving chemotherapy or \<50\*10\^9/L if receiving chemotherapy). Platelet count must have been \>100\*10\^9/L before starting study medication
  • One or more of the following: alanine aminotransferase \>3 times the upper limit of normal (ULN), total bilirubin \>2\*ULN, or calculated creatinine clearance \<30 mL/min.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Univ. Of Southern Calif. /Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Dana-Farber Cancer Inst

Boston, Massachusetts, 02115, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Mount Sinai School Of Medicine

New York, New York, 10029, United States

Location

University Of Rochester

Rochester, New York, 14642, United States

Location

University Of Texas Md Anderson Cancer Ctr

Houston, Texas, 77030, United States

Location

Local Institution

Hamilton, Ontario, L8V 2C5, Canada

Location

Local Institution

London, Ontario, N6A 4L6, Canada

Location

Local Institution

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Montreal, Quebec, H1T 2M4, Canada

Location

Local Institution

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (2)

  • Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7.

    PMID: 34622445DERIVED

  • Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

    PMID: 33337539DERIVED

Related Links

MeSH Terms

Conditions

ThrombosisNeoplasmsPulmonary Embolism

Interventions

apixaban

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

April 28, 2006

First Posted

May 3, 2006

Study Start

June 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 16, 2016

Results First Posted

August 16, 2016

Record last verified: 2016-08

Locations

CA(6)US(8)