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Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors

NCT01447732 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-04-29

No results posted yet for this study

Summary

This is a two-part, Phase 1 open label, multi-center, dose escalation study of CEP-37250/KHK2804 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.

Conditions

  • Solid Tumour
  • Adenocarcinoma of the Colorectal
  • Adenocarcinoma of the Pancreas

Interventions

DRUG

CEP-37250/KHK2804

Part 1 is based on the CEP-37250/KHK2804 tolerability and safety data from three subjects enrolled in a cohort, enrollment at the next dose level or additional subjects into the ongoing cohort will occur based upon the number subjects with DLT at a given dose level. Dose depends on subject's body weight. Part 1 includes intervention of CEP-37250/KHK2804. Part 2 will receive CEP-37250/KHK2804 at a dose to be determined following completion of Part 1.

Sponsors & Collaborators

  • Teva Pharma

    collaborator INDUSTRY

  • Kyowa Hakko Kirin Pharma, Inc.

    collaborator INDUSTRY

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Tirgan, MD · Kyowa Hakko Kirin Pharma, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-01-31
Completion
2015-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447732 on ClinicalTrials.gov