Selumetinib and Cixutumumab in Treating Patients With Advanced Solid Malignancies

Conditions

• Adult Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cixutumumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Selumetinib — DRUG
  Given PO

Study Details

This phase I clinical trial studies the safety and best dose of selumetinib and cixutumumab in treating patients with advanced solid malignancies. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry \[cancer/tumor\]-killing substances to them.

Key Dates

Start date

Nov 30, 2009

Status verified

Dec 2014

Primary completion

Apr 30, 2013

Completion

Sep 30, 2014

Study Design

Enrollment

30 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (selumetinib, cixutumumab)
  Patients receive selumetinib PO BID on days 1-28 and cixutumumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose of selumetinib in combination with cixutumumab defined as the dose produced DLT in =< 1 out of 6 patients [ Time Frame: Up to 4 weeks ]

Locations (1)

Find similar trials in Baltimore, MD