NCT02103062

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Abraxane (nab-paclitaxel) in subjects with previously treated metastatic colorectal cancer. Subjects will be placed into two separate cohorts based on their RAS mutation status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

6 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

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 5, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2015

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 20, 2016

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

March 31, 2014

Results QC Date

October 27, 2015

Last Update Submit

April 10, 2020

Conditions

Colorectal Neoplasms

Keywords

Metastatic Colorectal Cancernab®PaclitaxelResponse Evaluation in Solid TumorsProgression Free SurvivalOverall SurvivalDuration of ResponseRAS

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS) Rate as Measured at Week 8

    PFS rate was measured by Investigator Assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the start of study treatment to disease progression or death from any cause, whichever occurred first.

    At week 8 assessment period; up to 56 days

Secondary Outcomes (5)

  • Percentage of Participants With Stable Disease for ≥ 8 Weeks, or Complete or Partial Response According to RECIST Version 1.1; Disease Control Rate (DCR)

    At week 8 and later; up to day 241

  • Overall Survival

    Up to 241 days

  • Overall Response Rate (ORR)

    Up to 241 days

  • Duration of Response (DOR)

    Up to 241 days

  • Number of Participants With Adverse Events

    Time of the first dose of study treatment to 28 days after the last dose of study drug; maximum treatment duration was 24 weeks

Other Outcomes (1)

  • Kaplan Meier Estimate of PFS by Investigator Assessment

    Up to 241 days

Study Arms (1)

Abraxane (nab®paclitaxel)

EXPERIMENTAL

Abraxane (nab®paclitaxel) 125 milligrams per meter squared on days 1, 8 and 15 of a 28 day cycle

Drug: ABI-007

Interventions

ABI-007DRUG
Also known as: Abraxane (nab®paclitaxel)
Abraxane (nab®paclitaxel)

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique

Lille, 59020, France

Location

Centre Regional de Lutte contre le Cancer Val d'Aurelle

Montpellier, 34298, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

CRLCC Centre Rene Gauducheau

Saint-Herblain, 44805, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy Hematologie

Villejuif, 94805, France

Location

Related Publications (1)

  • Ducreux M, Bennouna J, Adenis A, Conroy T, Lievre A, Portales F, Jeanes J, Li L, Romano A. Efficacy and safety of nab-paclitaxel in patients with previously treated metastatic colorectal cancer: a phase II COLO-001 trial. Cancer Chemother Pharmacol. 2017 Jan;79(1):9-16. doi: 10.1007/s00280-016-3193-5. Epub 2016 Nov 19.

    PMID: 27866244DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization
Celgene Corporation
ClinicalTrialDisclosure@Celgene.com
888-260-1599

Study Officials

  • Alfredo Romano, MD

    Celgene

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

May 5, 2014

Primary Completion

November 10, 2014

Study Completion

January 9, 2015

Last Updated

April 21, 2020

Results First Posted

January 20, 2016

Record last verified: 2020-04

Locations

FR(6)