Calendario›CLRB›I-131-CLR1404
I-131-CLR1404
Dose Escalation Study of I-131-CLR1404 in Subjects With Cancer That Does Not Respond to Treatment or Has Returned
Ensayo de Cellectar Biosciences, Inc. en Cancer.
Más ensayos de: Cáncer.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 12
- Centros
- 3
- Fin del objetivo primario
- nov 2013
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2011.
Qué mide
Determination of the recommended dose of I-131-CLR1404 in treating subjects with relapsed or refractory advanced solid malignancies (Until non-tolerated dose is defined; dose escalation descision made upon review of data from a complete cohort (56 days after all subjects in cohort have received therapy infusion)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to determine the recommended dose of I-131-CLR1404, a radiolabeled therapy compound, for treating subjects with cancer that does not respond to treatment or has returned. The identified recommended dose in this study will be used as the optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase clinical development. Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated, the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable toxicity through 56 days after the therapy dose infusion with follow-up for up to one year. All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to injection of the dosimetric dose, and continuing for 14 days after the administration of the therapy dose.
Más ensayos de CLRB
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Iopofosine I 131 single dose · CLOVER-WaM | Fase 2 | En marcha, sin reclutar | jun 2026 (prevista, ya pasada: sin actualizar en el registro) |
| CLR 131 · CLOVER-2 | Fase 1 | En marcha, sin reclutar | jun 2027 (prevista) |
| CLR 131 | Fase 1 | En marcha, sin reclutar | jun 2027 (prevista) |
| Iopofosine I 131 | Fase 1 | Reclutando pacientes | feb 2028 (prevista) |
| Iopofosine I 131 | Fase 3 | Aún sin reclutar | ene 2032 (prevista) |
| I-131-CLR1404 | Fase 1 | Completado | dic 2020 (real) |
Todos los de CLRB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01495663), actualizada en feb 2015.