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Trial record 2 of 19 for:    Recruiting, Not yet recruiting, Available Studies | Adrenocortical carcinoma

Cabozantinib in Advanced Adrenocortical Carcinoma (CaboACC)

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ClinicalTrials.gov Identifier: NCT03612232
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital

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.


Condition or disease Intervention/treatment Phase
Adrenocortical Carcinoma Drug: Cabozantinib-s-malate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable/Metastatic Adrenocortical Carcinoma
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Cabozantinib
oral cabozantinib as tablets continuously (60 mg single dose, tablets)
Drug: Cabozantinib-s-malate
oral cabozantinib-S-malate 60 mg as a daily single oral dose continuously




Primary Outcome Measures :
  1. progression free survival at 4 months [ Time Frame: 4 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612232


Contacts
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Contact: Matthias Kroiss, MD, PhD +4993120139740 Kroiss_M@ukw.de
Contact: Martin Fassnacht, MD +49931201-39200 Fassnacht_M@ukw.de

Locations
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Germany
University Hospital Würzburg Recruiting
Würzburg, Germany, 97080
Contact: Matthias Kroiss, MD, PhD    +4993120139740    Kroiss_M@ukw.de   
Contact: Martin Fassnacht, MD    +4993120139200    Fassnacht_M@ukw.de   
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Principal Investigator: Matthias Kroiss, MD, PhD Wuerzburg University Hospital

Additional Information:
Publications:
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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT03612232     History of Changes
Other Study ID Numbers: CaboACC
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Wuerzburg University Hospital:
adrenal cancer
adrenal cortex neoplasm
adrenal cortical carcinoma
cabozantinib
c-MET
Additional relevant MeSH terms:
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Carcinoma
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases