Study With Cabazitaxel in Previously Treated Patients Wit... | NCT01956149

Studies
Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

NCT01956149

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Status

Completed

Last Update Posted

Apr 18, 2018Actual

Enrollment

65Actual

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

Cabazitaxel

Countries

Germany

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2017Actual

Completion Date

Apr 4, 2018Actual

First Submitted Date

Jul 3, 2013

First Submission Date that Met QC Criteria

Oct 1, 2013

First Posted Date

Oct 8, 2013Estimated

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

Apr 17, 2018

Last Update Posted Date

Apr 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.

Detailed Description

65 patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach will be treated with 20mg/m2 Cabazitaxel for a maximum of 6 cycles. Main objective of the study is the Disease Control Rate (DCR) with Cabazitaxel.

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

65Actual

Label	Type	Description	Intervention Names
Cabazitaxel	Experimental	Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22	Drug: Cabazitaxel

Name	Type	Description	Arm Group Labels	Other Names
Cabazitaxel	Drug	20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.	Cabazitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease Control Rate (DCR)	Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)	up to 17 months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	From date of randomization until the date of death from any cause, assessed up to 17 months	up to 17 months
Progression-free survival (PFS)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 17 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach
Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line.
Male and female patients aged > 18 years
ECOG ≤ 1
neutrophils ≥ 1500/µl
Haemoglobin ≥ 9 g/dl
Platelets ≥ 100,000/µl
AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;
Total bilirubin ≤1.0 x ULN
Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min
Written patient informed consent

Exclusion Criteria:

A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)
Active CAD, cardiomyopathy or NYHA stage III-IV heart failure
Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection
Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment
Peripheral polyneuropathy > NCI grade II
Severe hepatic impairment (AST/ALT > 2.5 x ULN, , bilirubin > 1 x ULN)
Chronic inflammatory bowel disease
Participation in another study
Pregnancy or lactation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Krankenhaus Dresden Friedrichstadt		Dresden			Germany
Krankenhaus Nordwest

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms