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JOURNAL ONKOLOGIE – STUDIE

A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

Rekrutierend

NCT-Nummer:
NCT02974725

Studienbeginn:
Februar 2017

Letztes Update:
13.04.2021

Wirkstoff:
LXH254, LTT462, Trametinib, Ribociclib

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Studienlocations
(3 von 34)

Novartis Investigative Site
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
60590 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
50937 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Sarah Cannon Research Institute Tennessee Oncology
37203 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Rita Baker
Phone: +1 615 329 7274
E-Mail: rita.baker@sarahcannon.com» Ansprechpartner anzeigen
Novartis Investigative Site
2145 Westmead
AustraliaRekrutierend» Google-Maps
Novartis Investigative Site
3000 Melbourne
AustraliaAktiv, nicht rekrutierend» Google-Maps
Novartis Investigative Site
3181 Prahran
AustraliaRekrutierend» Google-Maps
Novartis Investigative Site
69373 Lyon Cedex
FranceRekrutierend» Google-Maps
Novartis Investigative Site
75475 Paris Cedex 10
FranceRekrutierend» Google-Maps
Novartis Investigative Site
94800 Villejuif Cedex
FranceRekrutierend» Google-Maps
Novartis Investigative Site
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Novartis Investigative Site
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
02 781 Warszawa
PolandRekrutierend» Google-Maps
Novartis Investigative Site
171 76 Stockholm
SwedenRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

To characterize safety and tolerability and identify a recommended dose and regimen for the

LXH254 in combination with LTT462 or trametinib or ribociclib.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients must have advanced or metastatic NSCLC or cutaneous melanoma

- Presence of KRAS or BRAF mutation (NSCLC) or NRAS mutation (cutaneous melanoma) in

tumor tissue

- All patients participating in this clinical trial must have progressed following

standard therapy or, in the opinion of the Investigator, no effective standard therapy

exists, is tolerated, appropriate or is considered equivalent to study treatment.

- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

Exclusion Criteria:

-Dose expansion - KRAS or NRAS mutant patients groups: Prior treatment with a RAFi

(including any BRAFi and pan-RAFi), MEKi and/or ERKi. (Patients with KRAS mutant NSCLC with

prior G12C inhibitor treatments are also excluded in the LXH254+trametinib expansion part).

BRAF mutant patients group: Prior treatment with any EGFR, ALK, ROS1, KRAS, RAF (both

BRAFV600 selective and pan-RAF), MEK1/2 and/or ERK1/2 inhibitors (for patients with BRAF

V600 mutant NSCLC, prior treatments with BRAF and MEK1/2 inhibitors are allowed).

Patients who have received more than 3 lines of anti-cancer therapy are excluded.

- History or current evidence of retinal vein occlusion (RVO) or current risk factors

for RVO.

- Any medical condition that would, in the investigator's judgment, prevent the

patient's participation in the clinical study due to safety concerns or compliance

with clinical study procedures.

- Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days

prior to the start study treatment and for the duration of the study.

- Patients with Gilbert's syndrome or other heritable diseases of bile processing.

Other protocol-defined inclusion/exclusion criteria may apply

Studien-Rationale

Primary outcome:

1. Number of participants with Adverse Events (AEs) as a measure of safety and tolerability (Time Frame - up to 5 years)

2. Dose limiting toxicities (DLTs) (dose escalation only) (Time Frame - up to 3 years)

3. Tolerability measured by the number of subjects who have interruptions/reductions of study treatment and reason for interruptions/reductions (Time Frame - up to 5 years)

4. Tolerability measured by the dose intensity of study drug, Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intentity (Time Frame - Up to 5 years)

Secondary outcome:

1. Overall Response Rate (ORR) (Time Frame - Up to 5 years)

2. Duration of response (DOR) (Time Frame - Up to 5 years)

3. Disease Control Rate (DCR) (Time Frame - Up to 5 years)

4. Progression Free Survival (PFS) (Time Frame - Up to 5 years)

5. Overall Survival (OS) - (dose expansion part only) (Time Frame - Up to 6 years)

6. Derived PK parameter (Cmax) for LXH254 & LTT462: (Time Frame - Up to 5 years)

7. Derived PK parameter (AUC) for LXH254 & LTT462 (Time Frame - Up to 5 years)

8. Changes from baseline of pharmacodynamics (PD) marker DUSP6 in tumor samples (Time Frame - up to 5 years)

9. Derived PK parameter (Cmax) for LXH254 & trametinib (Time Frame - up to 5 years)

10. Derived PK parameter (AUC) for LXH254 & trametinib (Time Frame - Up to 5 years)

11. Derived PK parameter (Cmax) for LXH254 & ribociclib (Time Frame - Up to 5 years)

12. Derived PK parameter (AUC) for LXH254 & ribociclib (Time Frame - Up to 5 years)

Studien-Arme

  • Experimental: LXH254+LTT462
  • Experimental: LXH254+Trametinib
  • Experimental: LXH254+Ribociclib

Geprüfte Regime

  • LXH254:
    LXH254 will be supplied as tablet for oral use.
  • LTT462:
    LTT462 will be supplied as hard gelatin capsule for oral use.
  • Trametinib:
    Trametinib will be supplied as film-coated tablet for oral use
  • LXH254:
    Trametinib will be supplied as film-coated tablet for oral use
  • Ribociclib:
    Ribociclib will be supplied in tablets and hard gelatin capsules.

Quelle: ClinicalTrials.gov


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