Study of Karenitecin (BNP1350) to Treat Malignant Melanoma

Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma

Sponsoren

Hauptsponsor: BioNumerik Pharmaceuticals, Inc.

Mitarbeiter: Crown Bioscience, Inc. became karenitecin IND 057250 Sponsor on April 8, 2019

Quelle BioNumerik Pharmaceuticals, Inc.
Kurze Zusammenfassung

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

Gesamtstatus Completed
Anfangsdatum May 2002
Fertigstellungstermin November 2005
Primäres Abschlussdatum June 2003
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Overall Response start of treatment until progressive disease
Sekundäres Ergebnis
Messen Zeitfenster
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
Einschreibung 46
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Karenitecin (BNP1350)

Beschreibung: 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.

Armgruppenetikett: 1

Teilnahmeberechtigung

Kriterien:

- 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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Ort
Einrichtung: For Information call 210-614-1701 for a site near you
Standort Länder

United States

Überprüfungsdatum

March 2020

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: 1

Art: Experimental

Beschreibung: Karenitecin (BNP1350)

Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov