NCT00062491

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2003

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

June 6, 2003

Last Update Submit

March 10, 2020

Conditions

MelanomaNeoplasm

Outcome Measures

Primary Outcomes (1)

  • Overall Response

    start of treatment until progressive disease

Secondary Outcomes (4)

  • Objective Tumor Response Rate

    Start of treatment to date of response

  • Duration of Response

    Date of response to date of progressive disease

  • Overall Survival

    Randomization to date of death from any cause

  • Progression Free Survival

    Randomization to disease progression

Study Arms (1)

1

EXPERIMENTAL

Karenitecin (BNP1350)

Drug: Karenitecin (BNP1350)

Interventions

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

For Information call 210-614-1701 for a site near you

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

MelanomaNeoplasms

Interventions

cositecan

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2003

First Posted

June 12, 2003

Study Start

May 1, 2002

Primary Completion

June 1, 2003

Study Completion

November 1, 2005

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

US(1)