- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01504490
Phase I Study of CS-7017 and Bexarotene
A Phase I Study of a Combination of the Proteosome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene
This study is for patients with advanced solid tumors. The purpose of this study is to test the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer cells, including stopping cancer cells from growing and dividing, and causing the cancer cells to die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs together may have an even greater effect against cancer cells, hopefully, increasing the killing of cancer cells.
CS-7017 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene is an anti-cancer agent that has been approved by the FDA for patients with a specific type of cancer, cutaneous T-cell lymphoma.
This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene, has on cancer. This research is being done because it is not known if CS-7017 is safe to be given with Bexarotene.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20007
- Georgetown Lombardi Comprehensive Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Histologically proven advanced malignancy with measurable disease except for acute leukemias
- Progression on, or intolerance of, or ineligibility for all standard therapies
- Biopsy accessible tumor deposits
- LVEF >/= institutional normal
- No evidence of clinically significant fluid retention
- ECOG Performance status 0-2
- Subjects with no brain metastases or a history of previously treated brain metastases who have been treated with surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of intracranial disease and have not had treatment with steroids within one week of study enrollment.
- Adequate hepatic, bone marrow, and renal function
- Partial thromboplastin time must be </= 1.5 x upper limit of normal range and INR < 1.5. Subjects on anticoagulant will be permitted to enroll as long as the INR is in the acceptable therapeutic range
- Life expectancy > 12 weeks
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent.
Exclusion Criteria:
- Prior CS-7017 treatment
- Treatment with thiazolidinediones (TZDs) within 4 weeks prior to start of study treatment
- Current need for concomitant use of other TZDs during the study
- Grade 2 or greater fasting hypertriglyceridemia
- Concurrent use of insulin
- Concurrent use of known CYP 3A4 inhibiting or activating medications
- CNS metastases which do not meet the criteria outlines in inclusion criteria
- Active severe infection or known chronic infection with HIV or hepatitis B virus
- Cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke or congestive heart failure within the last 6 months
- Life-threatening visceral disease or other severe concurrent disease
- Women who are pregnant or breastfeeding
- Anticipated survival under 3 months
- Clinically significant and uncontrolled major medical condition(s)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: CS-7017 and Bexarotene
Combination of CS-7017 and Bexarotene
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CS-7017 will be administered orally, twice daily for 28 days of each 28-day cycle in escalating doses depending on cohort patient is assigned to. Bexarotene will be administered orally once daily for 28 days of each 28-day cycle. The dose a patient receives will depend on which cohort the patient is assigned to.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Maximum Tolerated Dose
Lasso di tempo: 12 months
|
The highest dose at which < 1 out of 6 subjects experienced a dose-limiting toxicity
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12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Response rate
Lasso di tempo: 4 months
|
Complete response + partial response
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4 months
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Disease control rate
Lasso di tempo: 4 months
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Response rate + stable disease
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4 months
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Pharmacodynamic effects
Lasso di tempo: Prior to treatment, Just prior to Day 1 and just prior to Day 15 of cycle 1
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PPAR-gamma and RXR analysis by immunohistochemistry; Tumor staining for the following PPAR-gamma regulated genes: Cyclin D1, p16, p18, p21, p27, and c-myc.
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Prior to treatment, Just prior to Day 1 and just prior to Day 15 of cycle 1
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Pharmacokinetics
Lasso di tempo: Day -7 prior to first dose of CS-7017, Day 1, and Day 15 of Cycle 1
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Trough serum levels of CS-7017 and its metabolites
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Day -7 prior to first dose of CS-7017, Day 1, and Day 15 of Cycle 1
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Collaboratori e investigatori
Sponsor
Collaboratori
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Malattie ematologiche
- Disturbi emorragici
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Neoplasie, plasmacellule
- Mieloma multiplo
- Agenti antineoplastici
- Bexarotene
- Efatutazone
Altri numeri di identificazione dello studio
- 2011-345
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 .
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