EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide

Merck KGaA (EMD Serono) logo

Merck KGaA (EMD Serono)

Status and phase

Completed
Phase 1

Conditions

Carcinoma, Non-small-cell Lung
Ovarian Cancer
Prostate Cancer
Colorectal Cancer

Treatments

Drug: EMD 273066

Study type

Interventional

Funder types

Industry

Identifiers

NCT00132522
EMR 62206-015

Details and patient eligibility

About

This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental biological drug that may increase the immune response to certain cancers. Patients will be enrolled in groups of 3, with each successive group receiving a higher dose if the prior group adequately tolerates the study medication.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Recurrent non-small cell lung, colorectal, ovarian or prostate cancer
  • No more than two lines of prior chemotherapy
  • Positive EpCAM expression
  • Karnofsky Performance Status > 70%
  • Adequate laboratory results
  • Normal cardiac stress test

Exclusion criteria

  • Evidence of brain metastases
  • Pregnant or lactating females
  • Significant infection
  • Prior receipt of EMD 273066
  • Unable to interrupt anti-hypertensive medications 2 days prior to and through each cycle of study medication administration
  • Uncontrolled hypertension
  • Previous diagnosis of Addison's disease
  • Previous diagnosis of an autoimmune disease
  • Organ transplant
  • Insulin-dependent diabetes
  • History of acute pancreatitis
  • Congestive heart failure

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Arm 1
Experimental group
Treatment:
Drug: EMD 273066

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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