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An Open Label, Parallel Group, Randomized Phase I Study of Biological Activity, Safety, Tolerability, and Clinical Activity of Different Dose Levels of EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

An Open Label, Parallel Group, Randomized Phase I Study of Biological Activity, Safety, Tolerability, and Clinical Activity of Different Dose Levels of EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors


Inclusion Criteria:



- Male and female subjects ≥18 years of age

- Signed written informed consent

- Histologically or cytologically documented metastatic or locally advanced
survivin-expressing solid tumor for which no established therapy exists

- Disease must be measurable by RECIST criteria or evaluable by clinical, radiographic,
or laboratory criteria established for the given tumor entity

- Expressing at least one of the following HLA alleles:HLA-A1,-A2,-A3,-A24, and -B7
assessed by HLAgenotyping

- ECOG performance status of ≤1, estimated life expectancy of at least 3 months

- Adequate hematological function defined by WBC ≥3 x 10x9/L, lymphocyte count ≥0.5 x
10x9/L, hemoglobin ≥10 g/dL, platelet count ≥100 x 10x9/L

- Adequate blood coagulation parameters defined as aPTT and INR ≤ 1.5 x ULN

- Adequate renal function defined by a serum creatinine ≤2 x ULN

- Adequate hepatic function defined by total bilirubin ≤2 x ULN and AST and ALT levels
≤2.5 x ULN (in subjects with liver metastases ≤5 x ULN)

- Effective contraception for female and male subjects if the risk of conception exists

Exclusion Criteria:

- Treatment in another clinical study within the past 30 days prior to the first
administration of study treatment

- Previous treatment with an investigational anticancer vaccine

- Requirement of concurrent treatment with a nonpermitted drug

- Active significant autoimmune disease (with the exception of vitiligo)

- Receipt of allogeneic stem cell transplantation

- Significant acute or chronic infections (e.g. viral hepatitis, HIV)

- Primary brain tumors and brain metastases (with the exception of brain metastases
that are stable after irradiation or surgically resected brain metastases if subjects
have been asymptomatic for ≥6 months)

- Rapidly progressive disease (e.g. tumor lysis syndrome)

- Radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy),
immunotherapy or any investigational drug within 30 days before the start of study
treatment

- Pregnancy or lactation

- Active drug or alcohol abuse

- Known hypersensitivity to the study treatment or any of its components

- Any significant disease that, in the Investigator's opinion, should exclude the
subject from the study; for questions about this criterion, the Investigator should
contact the sponsor.

- Persisting toxicity related to prior therapy ≥grade 2 National Cancer
Institute-Common Terminology Criteria For Adverse Events version 3.0

- Legal incapacity or limited legal capacity

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy

Outcome Time Frame:

1-4 weeks

Safety Issue:

No

Principal Investigator

Jens-Peter Marschner, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck KGaA, Darmstadt

Authority:

Switzerland: Swissmedic

Study ID:

EMR 200032-001

NCT ID:

NCT01012102

Start Date:

April 2008

Completion Date:

September 2011

Related Keywords:

  • Advanced Solid Tumors
  • EMD 640744
  • Montanide
  • Advanced solid tumours
  • Neoplasms

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