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JOURNAL ONKOLOGIE – STUDIE

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

Rekrutierend

NCT-Nummer:
NCT02719574

Studienbeginn:
April 2016

Letztes Update:
30.03.2021

Wirkstoff:
azacitidine, Cytarabine, FT-2102 (olutasidenib)

Indikation (Clinical Trials):
Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Preleukemia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Forma Therapeutics, Inc.

Collaborator:
-

Studienleiter

Emma Barrett
Study Director
Forma Therapeutics, Inc.

Kontakt

Studienlocations
(3 von 82)

Charite Universitaetsmedizin Berlin
Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Oliver Streitbürger
Phone: +495315953700
E-Mail: o.streitbuerger@klinikum-braunschweig.de
» Ansprechpartner anzeigen
Klinikum Chemnitz gGmbH - Klinik fuer Innere Medizin III
Chemnitz
(Sachsen)
GermanyZurückgezogen» Google-Maps
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin
Gießen
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Andreas Neubauer
E-Mail: sekretariat.onkologie@med.uni-marburg.de
» Ansprechpartner anzeigen
Universitätsklinikum Jena
Jena
(Thüringen)
GermanyZurückgezogen» Google-Maps
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
(Rheinland-Pfalz)
GermanyZurückgezogen» Google-Maps
Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi
Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Christin Böwing
Phone: +49 251 8344386
E-Mail: christin.boewing@ukmuenster.de
» Ansprechpartner anzeigen
Robert-Bosch-Krankenhaus (RBK) Onkologisches Zentrum
Stuttgart
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Florida Cancer Specialists
34232 Sarasota
United StatesZurückgezogen» Google-Maps
Indiana Blood and Marrow Transplantation Research, LLC
46237 Indianapolis
United StatesZurückgezogen» Google-Maps
New York Cancer Associates
11733 East Setauket
United StatesZurückgezogen» Google-Maps
Stony Brook University Hospital
11794 Stony Brook
United StatesZurückgezogen» Google-Maps
Houston Methodist Research Institute
77030 Houston
United StatesZurückgezogen» Google-Maps
Swedish Cancer Center
98104 Seattle
United StatesZurückgezogen» Google-Maps
Canberra Hospital & Health Service
Canberra
AustraliaZurückgezogen» Google-Maps
St Vincent's Hospital Sydney
2010 Darlinghurst
AustraliaZurückgezogen» Google-Maps
Kyungpook National University Hospital
700-721 Daegu
Korea, Republic ofZurückgezogen» Google-Maps
Severance Hospital, Yonsei Health System
03722 Seoul
Korea, Republic ofZurückgezogen» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofZurückgezogen» Google-Maps
START - Hospital Universitario Fundación Jiménez Díaz
Madrid
SpainZurückgezogen» Google-Maps
Hospital Marques de Valdecilla
39008 Santander
SpainZurückgezogen» Google-Maps
Clatterbridge Cancer Centre NHS Trust
L78XP Liverpool
United KingdomZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib)

as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the

study is split into 2 distinct parts: a dose escalation part, which will utilize an

open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) +

azacitidine (combination agent) administered via one or more intermittent dosing schedules

followed by a dose expansion part. The dose expansion part will enroll patients in up to 5

expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as

combination activity with azacitidine or cytarabine. Following the completion of the relevant

Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different

cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102

(olutasidenib) + azacitidine (combination) on various AML/MDS disease states.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic

leukemia [APL] with the t(15;17) translocation) or intermediate, high-risk, or very

high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization

(WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is

relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is

contraindicated or which has not adequately responded to standard therapy.

- Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site

- Good performance status

- Good kidney and liver function

Exclusion Criteria:

- Patients with symptomatic central nervous system (CNS) metastases or other tumor

location (such as spinal cord compression, other compressive mass, uncontrolled

painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention,

palliative care, surgery or radiation therapy

- Congestive heart failure (New York Heart Association Class III or IV) or unstable

angina pectoris. Previous history of myocardial infarction within 1 year prior to

study entry, uncontrolled hypertension or uncontrolled arrhythmias

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic

therapy

Studien-Rationale

Primary outcome:

1. Maximum Tolerated Doses (MTDs) or Maximum Evaluated Doses (MEDs) [Phase 1] (Time Frame - Within first 4 weeks of treatment)

2. Number of Participants with a Dose Limiting Toxicity (DLT) [Phase 1] (Time Frame - Within first 4 weeks of treatment)

3. Doses recommended for future studies [Phase 1] (Time Frame - Within first 4 weeks of treatment)

4. Complete Response (CR and CRh) Rate of FT-2102 (olutasidenib) single-agent or in combination with Azacitidine in patients with AML/MDS [Phase 2 Cohorts 1, 3-8] (Time Frame - As per modified IWG Response Assessment Guidelines for AML and MDS based on investigator's assessment on day 1 of each cycle through study completion)

5. 4-Month Relapse Free Survival (RFS) of FT-2102 (olutasidenib) single-agent [Phase 2 Cohort 2] (Time Frame - From time of entry on study through progression, up to 30 weeks, on average)

Secondary outcome:

1. Area under the plasma concentration versus time curve (AUC) [Phase 1 and Phase 2] (Time Frame - Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days)

2. Peak Plasma Concentration (Cmax) [Phase 1 and Phase 2] (Time Frame - Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days)

3. Time of peak plasma concentration Tmax [Phase 1 and Phase 2] (Time Frame - Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days)

4. Time for half of the drug to be absent in blood stream following dose (T 1/2) [Phase 1 and Phase 2] (Time Frame - Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days)

5. Rate at which drug is removed from blood stream (CL/F) [Phase 1 and Phase 2] (Time Frame - Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days)

6. Rate of drug distribution within the blood stream (Vd/F) [Phase 1 and Phase 2] (Time Frame - Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days)

7. Evidence of antileukemic or antimyelodysplastic activity of FT-2102 (olutasidenib) as determined by CR, CRh, CRi, MLFS, Marrow CR, PR, and SD as a single-agent or in combination with azacitidine or cytarabine [Phase 1] (Time Frame - As per modified IWG Response Assessment Guidelines for AML and MDS based on investigator's assessment on day 1 of each cycle through study completion)

8. Incidence and severity of adverse events, clinical laboratory abnormalities, and changes in ECG parameters as assessed by CTCAE v4.0 as a single-agent or in combination with azacitidine [Phase 2] (Time Frame - Safety will be assessed from time of first dose through 28 days post last dose.)

9. Additional measures of antileukemic or antimyelodysplastic activity as determined by CRi, MLFS, Marrow CR, PR, Overall Response (OR), and Stable Disease (SD) of FT-2102 (olutasidenib) alone or in combination with azacitidine [Phase 2] (Time Frame - As per modified IWG Response Assessment Guidelines for AML and MDS based on investigator's assessment on day 1 of each cycle through study completion)

10. Time to Response (TTR) [Phase 2] (Time Frame - From first dose of study drug through time of first response by blood recovery count, up to 30 weeks, on average)

11. Duration of Response (DOR) [Phase 2] (Time Frame - From time of first response by blood recovery count through relapse, up to 30 weeks, on average)

12. Event-Free Survival (EFS) [Phase 2] (Time Frame - From time of entry on study through progression, up to 30 weeks, on average)

13. Overall Survival (OS) [Phase 2] (Time Frame - From time of entry on study through death or date last known alive at end of follow-up, up to 30 weeks, on average)

14. Relapse Free Survival (RFS) [Phase 2] (Time Frame - From time of entry on study through progression, up to 30 weeks, on average)

Studien-Arme

  • Experimental: PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)
  • Experimental: PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
  • Experimental: PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
  • Experimental: PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
    Relapsed or Refractory (R/R) AML
  • Experimental: PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
    AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
  • Experimental: PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
    R/R AML/MDS, previously treated with FT-2102
  • Experimental: PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
    R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
  • Experimental: PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
    R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
  • Experimental: PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
    R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
  • Experimental: PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
    Treatment naïve AML for whom standard treatments are contraindicated
  • Experimental: PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
    Treatment naïve AML who are candidates for azacitidine first line treatment

Geprüfte Regime

  • FT-2102 (olutasidenib):
    FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
  • Azacitidine (Vidaza):
    azacitidine will be administered per site's standard of care
  • Cytarabine:
    low-dose cytarabine will be administered per site's standard of care

Quelle: ClinicalTrials.gov


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