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Trial Outcomes & Findings for Capecitabine With Digoxin for Metastatic Breast Cancer (NCT NCT01887288)

NCT ID: NCT01887288

Last Updated: 2018-02-22

Results Overview

Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

One year

Results posted on

2018-02-22

Participant Flow

Participant milestones

Participant milestones
Measure
Capecitabine With Digoxin
Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle (1 cycle - 4 weeks) Capecitabine: 650 mg/m\^2 PO b.i.d. Digoxin: 0.25 mg once daily
Overall Study
STARTED
16
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
16

Reasons for withdrawal

Reasons for withdrawal
Measure
Capecitabine With Digoxin
Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle (1 cycle - 4 weeks) Capecitabine: 650 mg/m\^2 PO b.i.d. Digoxin: 0.25 mg once daily
Overall Study
The study was terminated and the PI has
16

Baseline Characteristics

Capecitabine With Digoxin for Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: One year

Population: data were not collected

Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: data were not collected

Assess the activity of this combination in terms of overall clinical benefit rates (CBR), including complete response (CR), partial response (PR) or stable disease (SD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Outcome measures

Outcome data not reported

Adverse Events

Capecitabine With Digoxin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica L. Coats

CTCA

Phone: 6232073899

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place