Phase II Study of SPI-1620 in Combination With Docetaxel... | NCT01773785

Studies
Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer

NCT01773785

Sponsor

Spectrum Pharmaceuticals, Inc

Status

Terminated

Last Update Posted

Oct 13, 2021Actual

Enrollment

30Actual

Phase

Phase 2

Conditions

Biliary Cancer

Interventions

SPI-1620
Docetaxel

Countries

United States

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study completed the first phase and did not meet efficacy end point to enter into the randomized phase.

Expanded Access Info

Start Date

Apr 2013Actual

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Jan 14, 2013

First Submission Date that Met QC Criteria

Jan 18, 2013

First Posted Date

Jan 23, 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

Sep 30, 2021

Certification/Extension First Submitted that Passed QC Review

Sep 30, 2021

Certification/Extension First Posted Date

Oct 5, 2021Actual

Last Update Submitted Date

Oct 8, 2021

Last Update Posted Date

Oct 13, 2021Actual

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

The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPI-1620 & Docetaxel	Experimental	Patients will receive 11 μg/m2 of SPI-1620 intravenously over one minute. Ten minutes after (±2 min) SPI-1620 administration, patients will receive docetaxel 75 mg/m2 intravenous. This regimen will be repeated every 3-weeks cycles until progression or intolerable toxicity.	Drug: SPI-1620 Drug: Docetaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPI-1620	Drug	SPI-1620 11 μg/m2 will be given intravenously over 1 minute.	SPI-1620 & Docetaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival		18 months

Secondary Outcomes

Measure	Description	Time Frame
Overall response rate		18 months
Overall survival		18 months
Duration of Response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
Evaluable disease
ECOG PS ≤ 2
Adequate bone marrow, liver and renal function

Exclusion Criteria:

Treatment with more than one prior chemotherapy regimen
Known, uncontrolled CNS metastases
Baseline peripheral neuropathy ≥ grade 2.
Significant circulatory disorders in the past 6 months
Concomitant use of phosphodiesterase inhibitors

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D001661	Biliary Tract Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C074308	sovateltide
D000077143	Docetaxel

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided