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An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Chemo-refractory Melanoma

Thank you

Trial Information

An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma

This is a single agent 2-step phase 2 study with a one-year follow-up to evaluate the
antitumor activity of Sunitinib administered in treatment cycles of 6 weeks duration (4
weeks treatment and 2 weeks rest) in patients with chemo-refractory melanoma. If the first
step shows sufficient efficacy and tolerability the study will continue to step 2. Treatment
will continue for 9 months or until disease progression or until intolerable adverse events
occur. Subsequently the patients will be followed up for 1 year. Tumor assessment will be
performed at baseline, at the end of cycle 1,2,3 and subsequently at the end of every uneven
cycle (5,7,9,…).

A total of 40 patients will be enrolled in this trial.

Inclusion Criteria:

- Male and female patients aged 18 years and older.

- Diagnosis of unresectable (Stage III) or metastatic (Stage IV), histologically or
cytologically proven, melanoma without clinically meaningful surgical or
radiotherapeutical options except for mucosal or ocular origin of the primary tumor.

- Subjects must have completed a first or second line chemotherapy or be progressed
under chemotherapeutic treatment. The previous treatment must have included DTIC
alone or in combination

- Performance status of 0 to 2 on the ECOG scale

- Life expectancy > 12 weeks.

- Patients must be able to swallow Sunitinib capsules.

- Evidence of measurable disease according to the RECIST criteria

- Prior radiation therapy allowed if completed at least 2 weeks and any major surgery
allowed if completed at least 4 weeks prior to first dose of Sunitinib.

- Resolution of all acute toxic side effects of prior therapy or surgical procedures to
grade < 1 NCI-CTC (except for laboratory values).

- Adequate organ function including the following:

- platelets > 100 x 109/L

- hemoglobin > 8 g/dl

- absolute neutrophils count (AGC) > 1.5 x 109/L.

- Hepatic:

- bilirubin <=1.5 times upper limit of normal (ULN)

- aspartate transaminase (AST) and alanine transaminase (ALT) <=2.5 times normal
(AST and ALT <=5.0 times normal is acceptable if liver function abnormalities
are due to underlying malignancy).

- INR < 1.5 or a PTT within normal limits.

- Subjects must not have any evidence of a bleeding diathesis.

- Renal:

- Serum creatinine < 1.5 x ULN

- serum calcium < 1.2 mg/dl.

- Pancreatic:

- Serum lipase and amylase within normal range.

- Signed and dated informed consent

Exclusion Criteria:

- Prior treatment with ras-raf-MEK-ERK signaling pathway inhibitors (including
trastuzumab, sorafenib, farnesyl transferase inhibitors or MEK inhibitors), or
treatment with drugs which target VEGF (such as bevacizumab).

- Radiotherapy, except palliative radiotherapy during study participation as described.

- Known active infection (i.e. HIV, chronic hepatitis B or C, at the discretion of the

- History of organ allograft or stem cell transplantation.

- Coexisting second malignancy (excluding basal or squamous cell carcinoma of the skin,
superficial bladder cancer and in situ carcinoma of the cervix with no evidence of
recurrence) or history of prior malignancy

- Bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection (> hemicolectomie or extensive small intestine resection with
chronic diarrhea), Crohn's disease, ulcerative colitis.

- Current history of chronic diarrhea defined as persisting diarrhea for more than 3
weeks at study entry due to any reason.

- Any of the following events prior to starting the trial treatment: *clinically
evident congestive heart failure, as defined by New York Health Association (NYHA) >
class II

- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2

- Atrial fibrillation of any grade, or prolongation of the QTc interval to >450
msec for males or >470 msec for females.

- Subjects on beta-blockers and digoxin must be monitored closely

- QT-interval > 450 msec

- Risk factors for torsade-de-pointes-tachycardia (i.e.. Hypokalaemia, congenital

- Active coronary artery disease or ischemia (myocardial infarction within the last 6
months prior to study entry)

- Coronary/peripheral artery bypass graft

- Cerebrovascular accident or transient ischemic attack

- Active disseminated intravascular coagulation, or history of clinically significant
bleeding within the past 6 months, including gross hemoptysis or haematuria, or
underlying coagulopathy

- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
medical therapy).

- 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 trial participation or trial drug administration, or which, in the
judgment of the investigator, would make the patient inappropriate for entry into the

- Participation in any other clinical trial within the last 3 weeks.

- Pregnant or lactating women.

- Known allergic/hypersensitivity reaction to any of the components of the treatment,
or known drug abuse/alcohol abuse.

- Active CNS metastatic or meningeal tumors.

- Patients with seizure disorders requiring medication (such as antiepileptics, the use
of carbamazepine, phenytion an phenobarbital is prohibited).

Type of Study:


Study Design:

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

Outcome Measure:

clinical benefit rate cycle 1-3

Outcome Description:

clinical benefit rate defined as a CR + PR + SD > 4 months duration

Outcome Time Frame:

tumor assessment every 6 weeks

Safety Issue:


Principal Investigator

Elke Jäger, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Krankenhaus Nordwest


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2009

Completion Date:

May 2013

Related Keywords:

  • Chemo-refractory Melanoma
  • melanoma
  • sunitinib
  • Melanoma