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Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Adrenocortical Carcinoma

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Trial Information

Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy

Inclusion Criteria:

- Histologically confirmed diagnosis of ACC

- Locally advanced or metastatic disease not amenable to radical surgery resection

- Radiologically monitorable disease

- Progressing disease after one to three cytotoxic chemotherapy regimes including a
platin-based protocol

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Age ≥ 18 years

- Adequate bone marrow reserve (neutrophils ≥ 1500/mm³ and platelets ≥100.000/mm³) and
haemoglobin ≥ 9 g/dl

- Negative pregnancy test and effective contraception in pre-menopausal female and male

- Patient´s written informed consent

- Ability to comply with the protocol procedures

- If patients have been participated in another clinical trial evaluating treatment
options for ACC (e.g. FIRM-ACT), the patient can only be included in the SIRAC trial,

- the patient has discontinued study treatment of the previous trial according to
the protocol

- or the study chair of the previous trial gives written approval for inclusion of
this individual patient in the SIRAC trial.

Exclusion Criteria:

- History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ
cervical carcinoma, or other treated malignancies with no evidence of disease for at
least three years.

- Severe renal (serum creatinine > 2.5 x ULN) or hepatic insufficiency (ALT / AST > 2.5
x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying
malignancy and/or total serum bilirubin > 2.0 x ULN) and/or serum albumin < 3g/dl

- Any of the following within the 8 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, pulmonary embolism, or other severe thromboembolic event.

- Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, acute atrial fibrillation of any
grade, or prolongation of the QTc interval to >470 msec for females

- Left ventricular ejection fraction (LVEF) <45% as measured by echocardiogram

- NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment

- Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal
medical therapy)

- Pregnancy or breast feeding

- Previous treatment with Sunitinib or any other VEGF- or PDGF-pathway directed agent.

- Current treatment with strong CYP3A4 inhibitors or -inducers

- Current treatment with another investigational drug

- Current treatment with another anti-cancer drug

- Patients with ileus within the last 28 days

- Major surgery, radiation therapy, or systemic therapy within 3 weeks of first study
treatment. At least 7 days should elapse from the time of minor surgical procedure
including placement of an access device or fine needle aspiration before start of
study treatment

- Serious wounds that have not completely healed, active ulcer(s), or significant bone

- Prior radiation therapy to >25% of the bone marrow.

- Cachectic patients with a body mass index < 18 kg/m2

- Any other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would impart, in the judgment of the investigator, excess risk
associated with study participation or study drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of clinical benefit as measured by non progressing rate after 12 weeks of treatment with Sunitinib

Principal Investigator

Martin Fassnacht, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wuerzburg


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

July 2007

Completion Date:

June 2011

Related Keywords:

  • Adrenocortical Carcinoma
  • Adrenal cancer refractory to cytotoxic therapy
  • Sunitinib
  • Multitargeted tyrosine-kinase inhibitor
  • Carcinoma
  • Adrenocortical Carcinoma