Cabozantinib in Advanced Adrenocortical Carcinoma

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Brief Title

Cabozantinib in Advanced Adrenocortical Carcinoma

Official Title

Phase II Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable/Metastatic Adrenocortical Carcinoma

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

progression free survival at 4 months

Secondary Outcome

 Objective Response Rates (ORR)

Condition

Adrenocortical Carcinoma

Intervention

Cabozantinib-s-malate

Study Arms / Comparison Groups

 Cabozantinib
Description:  oral cabozantinib as tablets continuously (60 mg single dose, tablets)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

37

Start Date

June 4, 2019

Completion Date

June 2022

Primary Completion Date

December 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Matthias Kroiss, MD, PhD, +4993120139740, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT03612232

Organization ID

CaboACC


Responsible Party

Sponsor

Study Sponsor

Wuerzburg University Hospital


Study Sponsor

Matthias Kroiss, MD, PhD, Principal Investigator, Wuerzburg University Hospital


Verification Date

August 2019