AS703569 and Gemcitabine Combination in Advanced Malignancies
A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Histologically/cytologically confirmed diagnosis of measurable or assessable malignancy, who meets one of the following conditions:
Subject with a tumour for which gemcitabine is approved, Subject with a tumour for which gemcitabine is considered standard of care, Subject with other tumour type either refractory or intolerant to or for whom there is not an accepted standard treatment.
Male or female with at least 18 years of age. Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
No more than 3 prior chemotherapy regimens for advanced/metastatic disease.
At least 4 weeks since last chemotherapy, hormonal therapy, immunotherapy, biological or any other pharmacological or investigational treatment or radiotherapy (6 weeks wash-out for nitrosoureas and mitomycin C, 5 half-lives for non-cytotoxics). Subjects on chronic hormonal therapy may continue with the same treatment unchanged.
Adequate renal, hepatic and bone marrow functions (assessed 7 days before inclusion in the trial) as defined by:
Serum creatinine
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Regimen 1: AS703569/gemcitabine
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle
|
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
Altri nomi:
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
Altri nomi:
|
|
Sperimentale: Regimen 2: AS703569/gemcitabine
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle
|
Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
Altri nomi:
AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum tolerated dose (MTD)
Lasso di tempo: 21 days
|
To determine the maximum tolerated dose (MTD) during a 21-day cycle, for each of the two planned regimens using combination therapy with AS703569 and gemcitabine.
|
21 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Treatment-emergent adverse events (TEAE)
Lasso di tempo: Minimum 21 days or 1 cycle
|
Proportion/number of subjects with TEAE's during the first and subsequent treatment cycles in each cohort for each of the 2 regimens.
|
Minimum 21 days or 1 cycle
|
|
Progression-Free Survival (PFS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
Lasso di tempo: Variable
|
PFS time is defined as time (in months) from first drug intake to date of progression as reported and documented by the investigator (i.e.
radiological progression per Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or death from any cause.
|
Variable
|
|
Time to Tumor Progression (TTP) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
Lasso di tempo: Variable
|
TTP time is defined as the time (in months)from first drug intake to the date of progression, as reported and documented by the Investigator (i.e.
radiological progression per RECIST).
|
Variable
|
|
Overall Survival (OS) time (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
Lasso di tempo: Variable
|
OS time is defined as the time (in months) from first drug intake to any cause of death.
|
Variable
|
|
Progressive disease (PD)
Lasso di tempo: Every other cycle
|
Proportion of patients with progressive disease as assessed at the end of every other cycle according to disease-specific guidelines
|
Every other cycle
|
|
Best overall response (For subjects with locally advanced /metastatic pancreatic cancer included after completion of the dose escalation part)
Lasso di tempo: Every other cycle
|
For subjects with locally advanced /metastatic pancreatic cancer: Best overall response: presence of at least one confirmed Complete Response (CR) or confirmed Partial Response (PR) (using RECIST v1.0) during treatment in the 2 regimens as assessed at the end of every other cycle. |
Every other cycle
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Narmyn Rejeb, MD, Merck Serono S.A., Geneva
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 27902
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Tumore del pancreas
-
Zeba Ahmad, Ph.D.American Cancer Society, Inc.ReclutamentoCaregiving for CancerStati Uniti
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
Institut Cancerologie de l'OuestAttivo, non reclutanteQualità della vita al lavoro | Professionisti paramedici | Toccare Massaggio | Cancer CenterFrancia
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
Yonsei UniversityNon ancora reclutamentoRAS/BRAF Wild-Type Advanced Cancer MathementCorea, Repubblica di
-
NRG OncologyNational Cancer Institute (NCI)CompletatoCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea del Sud
-
Jonsson Comprehensive Cancer CenterReclutamentoAdenocarcinoma prostatico | Cancro alla prostata in stadio II AJCC v8 | Fase I Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsReclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Second Affiliated Hospital, School of Medicine,...Attivo, non reclutanteElettroacopuntura combinata con paclitaxel legato alla proteina e anticorpo PD-1 per il trattamento di seconda linea di HER2 negativo, PMMR/MSS Advanced Gastric CancerCina
Prove cliniche su AS703569/gemcitabine
-
EMD SeronoTerminatoNeoplasie ematologicheItalia, Stati Uniti, Svizzera, Belgio, Germania