Studie av ZIO-201 i Advanced Sarcoma
A Phase IB/IIA Study of the Safety and Activity of Intravenous Isophosphoramide Mustard (ZIO-201) in Patients With Advanced Sarcoma
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
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California
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Santa Monica, California, Förenta staterna
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Michigan
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Ann Arbor, Michigan, Förenta staterna
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Metastatic and /or unresectable disease state after previous standard chemotherapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Phase 1: Palifosfamide-lysine 590 mg/m²
Participants received palifosfamide-lysine 590 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Four participants were treated at this dose level. Dose escalation was discontinued after 2 of 4 participants experienced dose-limiting toxicities during Cycle 1. |
Palifosfamide-lysine (ZIO-201) was administered by intravenous infusion on Days 1, 2, and 3 of each 21-day cycle. Dose and formulation are specified in the corresponding Arm descriptions.
Andra namn:
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Experimentell: Phase 2: Palifosfamide-lysine 413 mg/m²
Participants received palifosfamide-lysine 413 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Forty-nine participants were treated at this dose level. The last 6 participants enrolled also participated in a pharmacokinetic substudy in which they received a single dose of palifosfamide-tris 178 mg/m² on Day -14 before beginning palifosfamide-lysine treatment. |
Palifosfamide-lysine (ZIO-201) was administered by intravenous infusion on Days 1, 2, and 3 of each 21-day cycle. Dose and formulation are specified in the corresponding Arm descriptions.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1
Tidsram: Cycle 1 (21 days)
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DLTs were assessed during the first 21-day cycle to determine the maximum tolerated dose (MTD). A DLT was defined as any of the following: a non-hematologic Grade 3 toxicity that did not resolve to Grade 2 or lower within 72 hours, excluding alopecia any non-hematologic Grade 4 toxicity, excluding alopecia Grade 4 granulocyte and/or platelet toxicity lasting 7 days or longer Grade 3 or higher neutropenia with an unexplained temperature of 38.5°C or higher on 2 or more occasions within 24 hours The MTD was the dose level below the dose at which at least 33% of participants had a DLT. |
Cycle 1 (21 days)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Maximum Plasma Concentration (Cmax) of Palifosfamide
Tidsram: Cycle 1, Days 1 to 3
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Cmax of palifosfamide, measured from blood samples collected during Cycle 1 dosing. |
Cycle 1, Days 1 to 3
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Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Palifosfamide
Tidsram: Cycle 1, Days 1 to 3
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AUC0-inf of palifosfamide, measured from blood samples collected during Cycle 1 dosing. |
Cycle 1, Days 1 to 3
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Jonathan Lewis, MD, PhD, ZIOPHARM Oncology, Inc
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IPM2001
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