Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

NCT00669019 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00193N01CM62201CDR000059472916077A
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well saracatinib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Conditions

Recurrent Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma; Stage IV Melanoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum LD; Objective response = CR + PR. CT scans will be performed at baseline and every 4-8 weeks while on study.

  Up to 25 weeks

Secondary Outcomes (1)

• Progression-free Survival

  Up to 2 years

Study Arms (1)

Saracatinib

EXPERIMENTAL

Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.

Drug: saracatinib

Interventions

saracatinib DRUG

Also known as: AZD0530

Saracatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic melanoma
• Stage IV or unresectable stage III disease
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral computed tomography (CT) scan
• No known brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy \> 12 weeks
• White blood cell (WBC) ≥ 3,000/mcL
• Absolute neutrophil count (ANC) ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin ≥ 9 g/dL
• Total bilirubin normal
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Proteinuria ≤ 1+ by dipstick OR 24-hour urine protein ≤ 1 g
• Not pregnant or nursing

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Trial was designed with a maximum target accrual of 37 patients. Per protocol, the trial was stopped after the first stage based on an interim analysis of the response rate among the first 23 patients.

Results Point of Contact

• Title: Dr. Thomas F. Gajewski
• Organization: University of Chicago

tgajewsk@medicine.bsd.uchicago.edu

773-702-4601

Study Officials

• Thomas Gajewski

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2008
• First Posted: April 29, 2008
• Study Start: July 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 21, 2014
• Results First Posted: January 27, 2014

Record last verified: 2014-01

Locations

US (1)