Trial Outcomes & Findings for Retrospective Data Collection: Post Study Treatment Anticancer Therapy From IMELDA MO22223 (NCT NCT02383576)

NCT ID: NCT02383576

Last Updated: 2018-04-13

Results Overview

Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.

Recruitment status

COMPLETED

Target enrollment

185 participants

Primary outcome timeframe

Up to 78 months

Results posted on

2018-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.	Bevacizumab and Capecitabine Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Overall Study STARTED	94	91
Overall Study COMPLETED	31	46
Overall Study NOT COMPLETED	63	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.	Bevacizumab and Capecitabine Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Overall Study Death	53	33
Overall Study Lost to Follow-up	7	1
Overall Study Withdrew Consent	1	6
Overall Study Investigator's Decision	0	1
Overall Study Administrative/Other	2	4

Baseline Characteristics

Retrospective Data Collection: Post Study Treatment Anticancer Therapy From IMELDA MO22223

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Up to 78 months

Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.

Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.

Outcome measures

Outcome measures
Measure	Bevacizumab n=59 Participants Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.	Bevacizumab and Capecitabine n=59 Participants Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy	93.2 percentage of participants	84.7 percentage of participants

PRIMARY outcome

Timeframe: Up to 78 months

Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.

Participants who received further anti-cancer therapies after discontinuation of study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.

Outcome measures

Outcome measures
Measure	Bevacizumab n=59 Participants Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.	Bevacizumab and Capecitabine n=59 Participants Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment	94.9 percentage of participants	91.5 percentage of participants

PRIMARY outcome

Timeframe: Up to 78 months

Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.

Time from last maintenance study medication to the start of any further anti-cancer therapy was reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.

Outcome measures

Outcome measures
Measure	Bevacizumab n=59 Participants Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.	Bevacizumab and Capecitabine n=59 Participants Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy	22.5 days Interval 0.0 to 70.0	23.5 days Interval 0.0 to 630.0

PRIMARY outcome

Timeframe: Up to 78 months

Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.

PFS was defined as the time from start of the study to the first documented occurrence of disease progression. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.

Outcome measures

Outcome measures
Measure	Bevacizumab n=59 Participants Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.	Bevacizumab and Capecitabine n=59 Participants Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Progression Free Survival (PFS)	4.3 months Interval 2.7 to 6.8	12.2 months Interval 7.6 to 15.4

PRIMARY outcome

Timeframe: Up to 78 months

Population: The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.

Overall survival was defined as the interval between start of the study and the date of death from any cause. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.

Outcome measures

Outcome measures
Measure	Bevacizumab n=59 Participants Participants who received bevacizumab in IMELDA (MO22223) P-trial and were in maintenance phase were observed.	Bevacizumab and Capecitabine n=59 Participants Participants who received bevacizumab and capecitabine in IMELDA (MO22223) P-trial and were in maintenance phase were observed.
Overall Survival	22.3 months Interval 12.1 to 29.8	36.5 months Interval 27.6 to Upper limit of 95% CI was not reached.

Adverse Events

Bevacizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bevacizumab and Capecitabine

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

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

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