NCT02654639

Brief Summary

Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

January 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 7, 2018

Completed
Last Updated

August 7, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

January 8, 2016

Results QC Date

April 17, 2018

Last Update Submit

July 11, 2018

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal CancerAdvanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Length of Progression-Free Survival

    Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.

    From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.

Study Arms (1)

TAS-102 and Bevacizumab

EXPERIMENTAL

Oral TAS-102 and intravenous Bevacizumab.

Drug: TAS-102Drug: Bevacizumab

Interventions

TAS-102DRUG

TAS-102 Twice a day by mouth day 1-5 and 8-12

Also known as: Lonsurf, Avastin
TAS-102 and Bevacizumab
BevacizumabDRUG

Bevacizumab by intravenous infusion once every 14 days

TAS-102 and Bevacizumab

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • Histologically proven, unresectable, evaluable metastatic colorectal cancer
  • to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based flourorpyrimidine-containing chemotherapy plus Bevacizumab
  • Patients must have stable disease (or better) during the initial induction chemotherapy with first-line chemotherapy.
  • No progressive disease at the time of initiation of maintenance therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
  • Adequate organ and marrow function
  • Women of child-bearing potential and men must agree to avoid pregnancy
  • Patient must start maintenance therapy at least 14 days after the last administered induction chemotherapy but no later than 30 days.

You may not qualify if:

  • Patients whose tumors have progressed on first-line treatment
  • Patients with active concurrent malignancy, other than superficial, non-invasive squamous cell carcinoma of the skin or uterine cervix, within the past three years.
  • Women who are pregnant or lactating
  • Unstable heart disease
  • Uncontrolled active infection requiring antibiotics within one week prior to first dose.
  • Patients with active CNS malignancy.
  • Persistent protein in the urine
  • Patients with bowel obstruction or uncontrolled vomiting.
  • Patients with serious psychiatric or medical conditions that could interfere with treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

  • Weinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80.

    PMID: 28712102DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

trifluridine tipiracil drug combinationBevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Mohamed Salem, MD
Organization
Levine Cancer Institute-Concord
mohamed.salem@lcic.edu
704-403-1370

Study Officials

  • Mohamed Salem, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 13, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 7, 2018

Results First Posted

August 7, 2018

Record last verified: 2018-04

Locations

US(1)