Cabozantinib in Advanced Adrenocortical Carcinoma (CaboACC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03612232|
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : August 5, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
oral cabozantinib as tablets continuously (60 mg single dose, tablets)
oral cabozantinib-S-malate 60 mg as a daily single oral dose continuously
- progression free survival at 4 months [ Time Frame: 4 months ]
- Objective Response Rates (ORR) [ Time Frame: 12 months ]
- Duration of response (DR) [ Time Frame: 12 months ]
- progression-free survival [ Time Frame: 12 months ]
- overall survival [ Time Frame: 12 months ]
- best percentage change in size of target lesions [ Time Frame: 12 months ]
- treatment emergent adverse events (CTC-AE 4.03) [ Time Frame: 12 months ]
- quality of life by EORTC QLQ-C30 [ Time Frame: 12 months ]
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
|Contact: Matthias Kroiss, MD, PhD||+4993120139740||Kroiss_M@ukw.de|
|Contact: Martin Fassnacht, MD||+49931201-39200||Fassnacht_M@ukw.de|
|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|
|Principal Investigator:||Matthias Kroiss, MD, PhD||Wuerzburg University Hospital|