Intervention: Sunitinib
Trial phase: Phase 2
ATC code: L01EX01
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(/C=C2\C(=O)Nc3ccc(F)cc32)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.

treatment will continue until progressive disease or unacceptable toxicity

Sunitinib :
Eligibility criteria:
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 patients
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, if:

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 fracture(s).
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.