The Safety and Efficacy of Pemetrexed Rechallenge With Be... | NCT02200354

Studies
The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

NCT02200354

Sponsor

Kobe City General Hospital

Status

Terminated

Last Update Posted

Aug 14, 2019Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Advanced Non-small Cell Lung Cancer

Interventions

pemetrexed with bevacizumab

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inclusion speed

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Mar 20, 2018Actual

Completion Date

Mar 20, 2019Actual

First Submitted Date

Jul 20, 2014

First Submission Date that Met QC Criteria

Jul 23, 2014

First Posted Date

Jul 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2019

Last Update Posted Date

Aug 14, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daichi Fujimoto, doctor, division of respiratory medicine, Kobe City General HospitalPrincipal Investigator

Lead Sponsor

Kobe City General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pemetrexed with bevacizumab	Experimental	pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1)	Drug: pemetrexed with bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pemetrexed with bevacizumab	Drug		pemetrexed with bevacizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival		Within the study period and until tumor proression, an expected average of 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
response rate		The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks
overall survival		From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20 Years and older
PS0-2
Advanced non-squamous non-small cell lung cancer; AND
Patients who have received more than 4 cycles of pemetrexed therapy before the study

Exclusion Criteria:

Interstitial pneumonia; AND
Abnormal blood test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daichi Fujimoto, MD	Kobe City Medical Center General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kobe City Medical Center General Hospital		Kobe	Hyōgo	650-0046	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D000068437	Pemetrexed
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574

Browse Leaves

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Browse Branches

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