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JOURNAL ONKOLOGIE – STUDIE
CaboACC

Cabozantinib in Advanced Adrenocortical Carcinoma

Rekrutierend

NCT-Nummer:
NCT03612232

Studienbeginn:
Juni 2019

Letztes Update:
05.08.2019

Wirkstoff:
Cabozantinib-s-malate

Indikation (Clinical Trials):
Carcinoma, Adrenocortical Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Wuerzburg University Hospital

Collaborator:
-

Studienleiter

Matthias Kroiss, MD, PhD
Principal Investigator
Wuerzburg University Hospital

Kontakt

Studienlocations
(1 von 1)

University Hospital Würzburg
97080 Würzburg
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Matthias Kroiss, MD, PhD
Phone: +4993120139740
E-Mail: Kroiss_M@ukw.de

Martin Fassnacht, MD
Phone: +4993120139200
E-Mail: Fassnacht_M@ukw.de
» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

Adrenocortical carcinoma is an orphan malignant disease that has a dismal prognosis in advanced stages. Mitotane is the only approved treatment but is limited by severe toxicity. Efficacy of mitotane is unsatisfactory with an objective response rate of ≈20% in monotherapy in selected patients (Megerle et al. JCEM 2018). Cytotoxic chemotherapy with etoposide, doxorubin and cisplatin (EDP) or streptozotocin in (Sz) addition to mitotane (Fassnacht et al., N Engl J Med 2012) succeeded in a progression-free survival of 5.6 months and 2.2 months, respectively in patients with advanced ACC. Objective response rates were 23 and 9%. EDP plus mitotane is therefore considered as standard treatment of ACC.

There is a need for more effective and less toxic treatments of ACC.

Results by Phan et al (Cancer Research, 2015) demonstrated expression of c-MET and its ligand HGF in ACC and provide a rationale to therapeutically target c-MET in ACC. In a case series of 7 patients with advanced ACC refractory to a median of 4 (2-8) prior lines of therapy, single agent treatment with cabozantinib as an off label therapy resulted in two partial responses and two additional cases of long-term disease stabilization (Wendler et al, ENDO 2018).

This is a prospective, non-randomized, open-label, single arm, single center phase II study to investigate the efficacy of oral continuous cabozantinib in adult patients with histologically confirmed adrenocortical carcinoma that is locally advanced or metastatic and who were refractory to or declined standard treatment. In patients previously on mitotane, mitotane administration must have been discontinued 28 days prior to study treatment and a mitotane serum concentration <2 mg/l has been documented.

Response rate will be calculated as the proportion of patients with progression-free survival at 4 months.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- histologically confirmed adrenocortical carcinoma that is locally advanced or metastatic who were refractory to or declined standard treatment.

- mitotane administration must have been discontinued 28 days prior to study treatment and a mitotane serum concentration <2 mg/l must be documented.

- measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;

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

- no major bone marrow and organ dysfunction

Exclusion Criteria:

- uncontrolled hypertension

- thromboembolic event 6 months prior to treatment initiation

- tumor manifestation with concern of fistula formation

- QT-interval of > 500 ms in ECG

Studien-Rationale

Primary outcome:

1. progression free survival at 4 months (Time Frame - 4 months)



Secondary outcome:

1. Objective Response Rates (ORR) (Time Frame - 12 months)

2. Duration of response (DR) (Time Frame - 12 months)

3. progression-free survival (Time Frame - 12 months)

4. overall survival (Time Frame - 12 months)

5. best percentage change in size of target lesions (Time Frame - 12 months)

6. treatment emergent adverse events (CTC-AE 4.03) (Time Frame - 12 months)

7. quality of life by EORTC QLQ-C30 (Time Frame - 12 months)

Geprüfte Regime

  • Cabozantinib-s-malate:
    oral cabozantinib-S-malate 60 mg as a daily single oral dose continuously

Quelle: ClinicalTrials.gov


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