- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03057366
A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors
A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]-Pevonedistat in Patients With Advanced Solid Tumors
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people with advanced solid tumors.
The study will enroll approximately 4 to 6 pharmacokinetics (PK)-evaluable participants in part A. After completion of the mass balance and absorption, distribution, metabolism, excretion (ADME) assessment in Part A of the study, eligible participants will have the opportunity to continue into Part B at a secondary study site, which would begin in approximately 2 weeks of completion of Part A.
- [14C]-Pevonedistat 25 mg/m^2
- Part B (optional): Pevonedistat in combination with chemotherapy regimens (Pevonedistat 25 mg/m^2 + docetaxel 75 mg/m^2 or pevonedistat 20 mg/m^2 + carboplatin 20 mg/m^2 + paclitaxel 175 mg/m^2)
All participants will receive study drug via intravenous route. This multi-center trial will be conducted in Hungary. Participants will remain confined to the study site for 9 to 14 days in Part A. Participation in Part B is optional, participants will be re-evaluated for inclusion/exclusion criteria before administrating treatment. Participants will undergo treatment in Part B for a maximum of 12 cycles (21 days cycle each) and will include approximately 36 weeks for Part A and B combined. Participants will attend an end of study visit 30 days after the last dose of study drug in both Part A and B.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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Budapest, Ungern, 1062
- Magyar Honvédség Egészségügyi Központ Onkológiai Osztály
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Budapest, Ungern, 1076
- PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is felt to be appropriate for treatment with one of the 2 chemotherapy regimens in Part B of this study (carboplatin+paclitaxel or docetaxel), or have progressed despite prior standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Expected survival longer than 3 months from enrollment in the study.
- Recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the effects of prior antineoplastic therapy.
Exclusion Criteria:
- Has irregular defecation patterns (less than 1 defecation per 2 days or excessive diarrhea) and/or has a history of changes in bowel habits with daily routine or environment changes.
- Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of the hematopoietically active bone marrow.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: [14C]-Pevonedistat 25 mg/m^2
[14C]-pevonedistat (containing approximately 60-98 mCi [approximately 2.22-3.626
MBq] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A. After completion of Part A, participants will have opportunity to continue into Part B. Participant will receive Pevonedistat 25 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21 day cycle, for up to 12 cycles along with docetaxel 75 mg/m^2, infusion, intravenously, over 1 hour on Day 1 of each 21 day cycle; or pevonedistat 20 mg/m^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21 day cycle, for up to 12 cycles, followed by paclitaxel 175 mg/m^2, infusion, intravenously, over 3 hours along with carboplatin 20 mg/m^2, infusion, intravenously, over 30 minutes on Day 1 of 21 each cycle up to 12 cycles.
Based on investigator and sponsor discretion, participants deriving benefits will continue to receive current combination therapy or pevonedistat alone beyond 12 cycles.
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Pevonedistat intravenös infusion.
Andra namn:
Docetaxel intravenös infusion.
Carboplatin intravenös infusion.
Paklitaxel intravenös infusion.
[14C]-Pevonedistat intravenous infusion.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Part A: Cmax: Maximum Observed Plasma and Whole Blood Concentration for Pevonedistat
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Pevonedistat
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Pevonedistat
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for [14C]-Pevonedistat Drug-related Material
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for [14C]-Pevonedistat Drug-related Material
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: AUClast: Area Under the Plasma and Whole Blood TRA Concentration Curve From Time 0 to Time of the Last Quantifiable Concentration for [14C]-Pevonedistat Drug-related Material
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Aeurine,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Urine up to the Last Sampling Interval
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Aefeces,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Feces up to the Last Sampling Interval
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Aetotal,14C: Total Cumulative Excretion of [14C]-Pevonedistat From the Body
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Aeurine: Cumulative Amount of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Feurine: Cumulative Percentage of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Part A: Renal Clearance (CLR) for Pevonedistat
Tidsram: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsram: Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)
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Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)
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Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Tidsram: Up to 168 hours post-dose
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Up to 168 hours post-dose
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Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
Tidsram: Up to Cycle 11 (Cycle length =21 days)
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The best overall response was defined as the participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD).
It was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
CR: disappearance of all target lesions.
Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm).
PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization.
SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
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Up to Cycle 11 (Cycle length =21 days)
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pevonedistat-1013
- U1111-1169-6648 (Registeridentifierare: WHO)
- 2016-004132-37 (EudraCT-nummer)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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