Study of Karenitecin (BNP1350) to Treat Malignant Melanoma | NCT00062491

Studies
Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

NCT00062491

Sponsor

BioNumerik Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Mar 12, 2020Actual

Enrollment

46Actual

Phase

Phase 2

Conditions

Melanoma
Neoplasm

Interventions

Karenitecin (BNP1350)

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

Mar 2020

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

May 2002

Primary Completion Date

Jun 2003Actual

Completion Date

Nov 2005Actual

First Submitted Date

Jun 6, 2003

First Submission Date that Met QC Criteria

Jun 11, 2003

First Posted Date

Jun 12, 2003Estimated

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

Mar 10, 2020

Last Update Posted Date

Mar 12, 2020Actual

Name	Class
Crown Bioscience	INDUSTRY

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 purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Karenitecin (BNP1350)	Drug: Karenitecin (BNP1350)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Karenitecin (BNP1350)	Drug	Karenitecn (1.0 mg/m2) administered as a single daily 60-minute intravenous infusion for 5 consecutive days repeated every 21 days (1 treatment cycle). Patients who respond (CR< PR, SD) can continue treatment for 6 cycles, unless unacceptable toxicity develops. Treatment will be discontinued if progressive disease or unacceptable toxicity develops.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response		start of treatment until progressive disease

Secondary Outcomes

Measure	Description	Time Frame
Objective Tumor Response Rate		Start of treatment to date of response
Duration of Response		Date of response to date of progressive disease
Overall Survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Confirmed diagnosis of malignant melanoma
Measurable disease
Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN
No prior treatment with other camptothecin drug.
≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C
ECOG Performance Status 0-1
Negative pregnancy test for female patients

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
For Information call 210-614-1701 for a site near you		Tampa	Florida	33612	United States

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D009369	Neoplasms

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C406143	cositecan

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided