- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02537561
Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors
A Phase I Adaptive Design Trial of Talazoparib in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically confirmed diagnosis of advanced solid tumor for which no curative standard treatment options exist and for which gemcitabine and cisplatin is a suitable treatment regimen.
- After the determination of the maximum tolerated dose, an expansion cohort of 20 patients with non-small cell lung cancer whose tumors demonstrate variants in DNA repair pathway genes will be enrolled.
- Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
- Prior treatment for this disease is allowed if it has been completed at least 2 weeks prior to study enrollment and if all treatment-related toxicities are resolved. Prior exposure to a PARP inhibitor is allowed for patients in the dose-finding portion of the study.
- At least 18 years of age.
- ECOG performance status ≤ 1
Normal bone marrow and organ function as defined below:
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 100,000/mcl
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Tissue available for sequencing (either archival tissue or readily accessible tumor for fresh routine biopsy).
- Able to swallow tablets.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Received any other investigational agent within 2 weeks of starting the first dose on study.
- Symptomatic brain metastases. Known brain metastases are allowed if asymptomatic and previously treated. Patients must be at least 4 weeks post-brain radiation therapy.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, gemcitabine, talazoparib, or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active coronary artery disease, uncontrolled seizure, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Known HIV-positivity.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Arm 1: Cisplatin, Gemcitabine, Talazoparib Solid Tumors
|
Andre navne:
Andre navne:
Andre navne:
|
Eksperimentel: Arm 2: Cisplatin, Gemcitabine, Talazoparib NSCLC
|
Andre navne:
Andre navne:
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Safety and toxicities as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Tidsramme: 30 days after completion of treatment (estimated average to be 7 months)
|
30 days after completion of treatment (estimated average to be 7 months)
|
|
Maximum tolerated dose (MTD)
Tidsramme: Completion of dose escalation portion of study (approximately 12 months)
|
The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 30% of patients in a cohort are expected to experience a dose-limiting toxicity (DLT) during the second cycle based on the CRM algorithm.
Dose escalations will proceed until the MTD is determined.
|
Completion of dose escalation portion of study (approximately 12 months)
|
Objective response rate (ORR) in preselected patients with BRCAness tumoral genotype
Tidsramme: Up to completion of treatment (estimated average of 6 months)
|
ORR - proportion of patients who achieved a complete response or a partial response
|
Up to completion of treatment (estimated average of 6 months)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Disease control rate (DCR)
Tidsramme: Until death (estimated average to be 12 months)
|
|
Until death (estimated average to be 12 months)
|
Progression-free survival (PFS)
Tidsramme: Until death (estimated average to be 12 months)
|
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. -Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one more new lesions PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. |
Until death (estimated average to be 12 months)
|
Objective response rate (ORR)
Tidsramme: Up to completion of treatment (estimated average of 6 months)
|
ORR - proportion of patients who achieved a complete response or a partial response
|
Up to completion of treatment (estimated average of 6 months)
|
Overall survival (OS)
Tidsramme: Until death (estimated average to be 12 months)
|
OS: duration of time from start of treatment to time of death from any cause
|
Until death (estimated average to be 12 months)
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer efter histologisk type
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Karcinom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Poly(ADP-ribose) polymerasehæmmere
- Gemcitabin
- Cisplatin
- Talazoparib
Andre undersøgelses-id-numre
- 15-x279
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Ikke-småcellet lungekræft
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AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
-
Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
Kliniske forsøg med Gemcitabin
-
AstraZenecaRekrutteringGaldevejskræftFrankrig, Spanien, Italien, Korea, Republikken, Japan, Tyskland, Forenede Stater, Singapore
-
Sierra Oncology LLC - a GSK companyAfsluttetAvancerede solide tumorerSpanien, Det Forenede Kongerige
-
Shenzhen University General HospitalIkke rekrutterer endnu
-
University of Erlangen-Nürnberg Medical SchoolAfsluttetKræft i bugspytkirtlenTyskland
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRekruttering
-
Kansai Hepatobiliary Oncology GroupAfsluttet
-
Samsung Medical CenterAfsluttetKræft i bugspytkirtlenKorea, Republikken
-
3D Medicines (Sichuan) Co., Ltd.Ikke rekrutterer endnuGaldevejsneoplasmer
-
Centro Nacional de Investigaciones Oncologicas...Apices Soluciones S.L.; Hospital Universitario de Fuenlabrada; Grupo Hospital...AfsluttetAvanceret pancreascarcinomSpanien
-
University of ZurichAfsluttetKræft i bugspytkirtlenFrankrig, Schweiz, Belgien, Tyskland