A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
NCT01551459
ABOUT THIS STUDY
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- Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (histology must be available from a metastatic site)
- Patients with disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent No prior systemic therapy for advanced disease, including regional delivery of drug therapy (prior surgery or radiofrequency ablation is acceptable)
- Patients who have received prior radiotherapy are eligible, however, measurable lesions must not have been previously irradiated
- Life expectancy > 12 weeks ECOG Performance status 0, 1 or 2
- At least one measurable target lesion, for further evaluation according to the Response Evaluation Criteria In Solid Tumours - RECIST version 1.1 completed within 28 days of randomisation
- Aged > 18 years
- Adequate haematological, renal and liver function as defined below and performed within 14 days of study inclusion:
Hb > 10 g/dl, platelets > 100 x109/L, WCC > 3.0 x109/L, ANC > 1.5x109/L, Bili < 1.5 x ULN, Alk phos < 5 x ULN, transaminases < 5 x ULN, Cr < 1.5 x ULN
- Able to provide written informed consent
- Females of child-bearing potential who have a negative pregnancy test prior to study entry and be using adequate contraception, which they agree to continue for 12 months after the study treatment
Patients who have:
- Conjunctival melanoma
- Received any previous systemic therapy for uveal melanoma
- Known leptomeningeal or brain metastases
- Patients with a history of prior malignant disease (unless they have had more than 3
years free of disease or have had adequately treated non-melanomatous skin cancer or
in situ carcinoma of the cervix)
- Had treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days
respectively, prior to study treatment administration
- Therapeutic anticoagulation for treatment of DVT/PE. Concomitant treatment with
therapeutic doses of anticoagulants (low dose warfarin up to 2mg PO daily for deep
vein thrombosis prophylaxis is allowed)
- Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite
optimal medical therapy) or active uncontrolled infections
- Any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- Clinically significant abnormal cardiac function with abnormal 12 lead ECG. Ongoing
cardiac dysrhythmias of NCI CTCAE grade 2, poorly controlled atrial fibrillation of
any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for
females
- Any other serious or uncontrolled illness which, in the opinion of the investigator,
makes it undesirable for the patient to enter the trial
- Any medical or psychiatric condition which would influence the ability to provide
informed consent
- Pregnant or lactating women Lack of informed consent
- Any previous investigational agent within the last 12 weeks
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma | |||
Official Title ICMJE | A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma | |||
Brief Summary | Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer spreads, it is more difficult to treat. Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine, but they are always looking to find new ways to treat uveal melanoma. This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse. | |||
Detailed Description | 124 eligible patients will be randomised to either Sunitinib or Dacarbazine treatment. Participants will then attend 3-weekly clinic visits and undergo 12-weekly tumour assessment (CT or MRI scan) until disease progression (according to RECIST 1.1) has been identified. At progression, patients may crossover to the other study treatment and continue with 3-weekly clinic visits and 12-weekly imaging until second progression. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Metastatic Uveal Melanoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 124 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2017 | |||
Actual Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Hb > 10 g/dl, platelets > 100 x109/L, WCC > 3.0 x109/L, ANC > 1.5x109/L, Bili < 1.5 x ULN, Alk phos < 5 x ULN, transaminases < 5 x ULN, Cr < 1.5 x ULN
Exclusion Criteria: Patients who have:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01551459 | |||
Other Study ID Numbers ICMJE | 2008-008794-55 2008-008794-55 ( EudraCT Number ) 8440 ( Other Identifier: UKCRN ) 75033520 ( Other Identifier: ISRCTN ) 10/H0904/15 ( Other Identifier: Sunderland Research Ethics Committee ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | The Clatterbridge Cancer Centre NHS Foundation Trust | |||
Study Sponsor ICMJE | The Clatterbridge Cancer Centre NHS Foundation Trust | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | The Clatterbridge Cancer Centre NHS Foundation Trust | |||
Verification Date | May 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |