Trial Outcomes & Findings for An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM) (NCT NCT01697462)
NCT ID: NCT01697462
Last Updated: 2016-01-26
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.
COMPLETED
258 participants
Baseline up to end of study (up to 42 months)
2016-01-26
Participant Flow
Participant milestones
| Measure |
mCRC Participants
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
|
|---|---|
|
Overall Study
STARTED
|
258
|
|
Overall Study
COMPLETED
|
181
|
|
Overall Study
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
mCRC Participants
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
|
|---|---|
|
Overall Study
Disease Progression
|
1
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Lost to Follow-up
|
21
|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Investigator Decision
|
21
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
10
|
|
Overall Study
Missing
|
5
|
Baseline Characteristics
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)
Baseline characteristics by cohort
| Measure |
mCRC Participants
n=258 Participants
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
|
|---|---|
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Age, Continuous
|
65.38 Years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study (up to 42 months)Population: Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.
Outcome measures
| Measure |
mCRC Participants
n=258 Participants
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
|
|---|---|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Non-Serious AEs
|
132 Participants
|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline to progressive disease or death (up to 42 months)Population: ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.
Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.
Outcome measures
| Measure |
mCRC Participants
n=257 Participants
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
|
|---|---|
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Percentage of Participants With Disease Progression
|
70.8 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline to progressive disease or death (up to 42 months)Population: ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.
PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.
Outcome measures
| Measure |
mCRC Participants
n=257 Participants
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
|
|---|---|
|
Progression-Free Survival (PFS)
|
4 Months
Interval 3.64 to 4.35
|
SECONDARY outcome
Timeframe: Baseline up to end of study (up to 42 months)Population: ITT population.
HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.
Outcome measures
| Measure |
mCRC Participants
n=258 Participants
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
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|---|---|
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Number of Participants With Hand-Foot Syndrome (HFS)
|
79 Participants
|
Adverse Events
mCRC Participants
Serious adverse events
| Measure |
mCRC Participants
n=258 participants at risk
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
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|---|---|
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Infections and infestations
Pneumonia
|
0.39%
1/258 • Baseline up to end of study (up to 42 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.39%
1/258 • Baseline up to end of study (up to 42 months)
|
|
Cardiac disorders
Cardiotoxicity
|
0.39%
1/258 • Baseline up to end of study (up to 42 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.39%
1/258 • Baseline up to end of study (up to 42 months)
|
|
Vascular disorders
Thrombophlebitis
|
0.39%
1/258 • Baseline up to end of study (up to 42 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
3/258 • Baseline up to end of study (up to 42 months)
|
|
Gastrointestinal disorders
Nausea
|
0.78%
2/258 • Baseline up to end of study (up to 42 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.78%
2/258 • Baseline up to end of study (up to 42 months)
|
|
General disorders
Chest pain
|
0.39%
1/258 • Baseline up to end of study (up to 42 months)
|
Other adverse events
| Measure |
mCRC Participants
n=258 participants at risk
Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
30.6%
79/258 • Baseline up to end of study (up to 42 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
35/258 • Baseline up to end of study (up to 42 months)
|
|
Gastrointestinal disorders
Nausea
|
17.8%
46/258 • Baseline up to end of study (up to 42 months)
|
|
Gastrointestinal disorders
Stomatitis
|
10.1%
26/258 • Baseline up to end of study (up to 42 months)
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
14/258 • Baseline up to end of study (up to 42 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER