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JOURNAL ONKOLOGIE – STUDIE

A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

Rekrutierend

NCT-Nummer:
NCT04042116

Studienbeginn:
Juli 2019

Letztes Update:
21.06.2021

Wirkstoff:
lucitanib, Nivolumab

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Clovis Oncology, Inc.

Collaborator:
Bristol-Myers Squibb, European Network of Gynaecological Oncological Trial Groups (ENGOT),

Studienleiter

Erika Hamilton, MD
Principal Investigator
Tennessee Oncology, PLLC
Nicole Concin, MD
Principal Investigator
KEM Kliniken Essen Mitte Evang. Huyssens-Stiftung

Kontakt

Clovis Oncology For North America, Latin America and Asia Pacific inquiries:
Kontakt:
Phone: 1-415-409-7220, 1-844-258-7662
E-Mail: medinfo@clovisoncology.com
» Kontaktdaten anzeigen
Clovis Oncology For Europe and Rest of World related inquiries:
Kontakt:
Phone: +353 16950030 (toll-paid)
E-Mail: MedInfo.IE@clovisoncology.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 24)

Interdisziplinäres Brustkrebszentrum Kliniken Essen-Mitte
Henricistraße 92
45136 Essen
(Nordrhein-Westfalen)
DeutschlandRekrutierend» Google-Maps
UCLA Jonsson Comprehensive Cancer Center
90095 Los Angeles
United StatesRekrutierend» Google-Maps
UC San Diego Moores Cancer Center
92093 San Diego
United StatesRekrutierend» Google-Maps
Anschutz Cancer Pavilion
80045 Aurora
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists
34232 Sarasota
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
NYU Langone Laura and Isaac Perlmutter Cancer Center
10016 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Duke University School of Medicine
27710 Durham
United StatesRekrutierend» Google-Maps
Ohio State University Wexner Medical Center
43210 Columbus
United StatesRekrutierend» Google-Maps
Stephenson Cancer Center
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Magee-Womens Hospital of UPMC
15213 Pittsburgh
United StatesRekrutierend» Google-Maps
Swedish Cancer Institute
98107 Seattle
United StatesRekrutierend» Google-Maps
Medical University of Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Saint Luc Univerisity Hospital
1200 Brussels
BelgiumRekrutierend» Google-Maps
University Hospitals Leuven, Campus Gasthuisberg
3000 Leuven
BelgiumRekrutierend» Google-Maps
National Cancer Institute -IRCCS "Fondazione G. Pascale
80131 Naples
ItalyRekrutierend» Google-Maps
University Hospital Reina Sofia
14004 Cordoba
SpainRekrutierend» Google-Maps
University Hospital Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in

combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by

evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced

gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed

state (Food Effect)

Ein-/Ausschlusskriterien

General Inclusion Criteria:

- ≥ 18 years of age

- Adequate organ function

- Life expectancy ≥ 3 months

- Women of childbearing potential must have a negative serum pregnancy test

- Advanced/metastatic solid tumor (Phase 1b)

- Availability of tumor tissue at screening

- ECOG performance status of 0 to 1

- Measurable disease (RECIST v1.1) (Phase 2)

- Advanced, recurrent, or metastatic gynecological solid tumor (Phase 2)

- Willing and able to fast, and to eat a high-fat breakfast (Food Effect)

General Exclusion Criteria:

- Prior treatment with lucitanib

- Active second malignancy

- Active central nervous system brain metastases

- Pre-existing duodenal stent or any gastrointestinal disorder

- Known history of HIV or AIDs; positive result of hepatitis B or C viruses

- Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of

myocarditis

- Active, known or suspected autoimmune disease (eg, autoimmune hepatitis)

- Condition requiring systemic treatment with corticosteroids or other immune

suppressive medications

- Unstable or uncontrolled hypertension (BP ≥ 140/90 mmHg)

- Prior treatment with a VEGFR-tyrosine kinase inhibitor (Phase 2)

Studien-Rationale

Primary outcome:

1. Determine the recommended Phase 2 dose of the combination of lucitanib and nivolumab (Phase 1b) (Time Frame - First dose of study drug through at least 100 days after end of treatment (up to approximately 2 years)):
Incidence of adverse events and clinical lab abnormalities defined as dose-limiting toxicities and maximum tolerated dose.

2. Best Overall Response Rate (Phase 2) (Time Frame - From first dose of study drug until disease progression (up to approximately 2 years)):
Confirmed best overall response (PR or CR) based on investigator assessment of objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary outcome:

1. Acute and long-term safety and tolerability of the combination (Phase 2) (Time Frame - From first dose of study drug until disease progression (up to approximately 2 years)):
Incidence of AEs, clinical lab abnormalities, and dose modifications.

2. Further evaluation of preliminary efficacy of combination (Phase 2) (Time Frame - From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years)):
Duration of response, progression-free survival, and disease control per RECIST v1.1, overall survival.

3. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] (Time Frame - From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)):
Area under the curve [AUCss]

4. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] (Time Frame - From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)):
Maximum plasma concentration [Cmax,ss]

5. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect] (Time Frame - From first dose of study drug to the end of Cycle 1 (each cycle is 28 days)):
Total clearance of drug after oral administration [CLss/F]

6. Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect, Phase 2] (Time Frame - From Cycle 2 to Cycle 5 (each cycle is 28 days)):
Minimum plasma concentration [Cmin,ss]

7. Lucitanib PK Profile at single dose [Food Effect Cohort] (Time Frame - From first dose of study drug to Day -1):
Area under the curve [AUC]

8. Lucitanib PK Profile at single dose [Food Effect Cohort] (Time Frame - From first dose of study drug to Day -1):
Maximum plasma concentration [Cmax]

9. Lucitanib PK Profile at single dose [Food Effect Cohort] (Time Frame - From first dose of study drug to Day -1):
Time to maximum plasma concentration [Tmax]

10. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] (Time Frame - From first dose of study drug to Day -1):
Area under the curve [AUC]

11. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] (Time Frame - From first dose of study drug to Day -1):
Maximum plasma concentration [Cmax]

12. The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort] (Time Frame - From first dose of study drug to Day -1):
Time to maximum plasma concentration [Tmax]

Studien-Arme

  • Experimental: Phase 1b: Dose Escalation
    - Up to 50 patients with advanced solid tumor
  • Experimental: Phase 1b: Food Effect Cohort
    - Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
  • Experimental: Phase 2: Expansion Cohort - Endometrial Cancer
    Recurrent endometrial carcinoma at least 1 prior platinum-based chemotherapy regimen Up to 10 patients who have progressed on treatment with 1 prior PD-(L)1 inhibitor administered as monotherapy will be allowed to enroll
  • Experimental: Phase 2: Expansion Cohort - Ovarian Cancer
    Recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma At least 2 prior chemotherapy regimens which at least 1 must have been platinum-doublet chemotherapy Up to 10 subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma who have progressed within 6 months after completing first-line platinum-based chemotherapy will be allowed to enroll
  • Experimental: Phase 2: Expansion Cohort - Clear Cell Cancer
    Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin At least 1 prior platinum- and taxane-based chemotherapy regimen
  • Experimental: Phase 2: Expansion Cohort - Cervical Cancer
    Persistent or recurrent cervix cancer of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma histology At least 1 prior regimen of platinum-based chemotherapy, with or without bevacizumab, for metastatic disease

Geprüfte Regime

  • Lucitanib (CO-3810):
    Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
  • Lucitanib (CO-3810):
    Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.
  • Lucitanib (CO-3810):
    Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg. Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria.
  • Nivolumab (Opdivo / BMS-936558 / ):
    IV nivolumab 480 mg will be administered once every 4 weeks.

Quelle: ClinicalTrials.gov


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