A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patien... | Not Recruiting
A Phase II Study of Sunitinib Versu... | Not Recruiting
A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
SUAVE

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Metastatic Uveal Melanoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01551459

We need your help to advance medical research

You can help accelerate the discovery of cures of medical conditions by signing up and creating a profile. By doing so you can register your interest in clinical trials and researchers will be able to get in touch about trials that are suitable for you.

This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Dacarbazine, Drug : Sunitinib

Study Arm Groups : Arm 1: Dacarbazine, Arm 2: Sunitinib

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression Free Survival; Once all patients have been followed up for at least 3 months
Secondary Outcome Measures
    Overall Survival; Analysis will take place once all patients have been followed up for at least 3 months; Overall Response Rate; Analysis will take place once all patients have been followed up for at least 3 months; Time to progression on first-line treatment compared to second-line treatment; Analysis will take place once all patients have been followed up for at least 3 months; Overall response rate on first-line treatment compared to overall response rate on second-line treatment for patients who receive cross-over therapy; Analysis will take place once all patients have been followed up for at least 3 months; Assessment of Adverse Events; Analysis will take place once all patients have been followed up for at least 3 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
124
Participant Inclusion Criteria
    Inclusion Criteria:

    - 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

    Exclusion Criteria:

    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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
The Clatterbridge Cancer Centre NHS Foundation Trust
Birkenhead
CH63 4JY
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
EudraCT Number
Not available for this trial
Funder(s)
  • Cancer Research UK
  • Pfizer
Other Study ID Numbers
2008-008794-55
Sponsor(s)
The Clatterbridge Cancer Centre NHS Foundation Trust
Key Dates

Recruitment Start Date

Oct 2010

Recruitment End Date

Feb 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

08 Mar 2012

Date updated in source

26 Jan 2016