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Dose Escalation Study of TriN2755 in Advanced Solid Tumors and Sarcomas

NCT01259518 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-06-08

No results posted yet for this study

Summary

This is an open-label, parallel-group, two-center, safety, activity and pharmacokinetic study of TriN 2755 given at increasing dose levels as intravenous infusions administered over 4 hours. The study is divided into two parts: Part I a dose escalation phase and Part II an extension phase.

Conditions

  • Neoplasms

Interventions

DRUG

TRIN2755

In treatment schedule A (Group A), the planned starting dose to be investigated is 25 mg TriN 2755 given once followed by a recovery period of 4 weeks. Subsequent patients can only be included on a new dose level when the safety review from all patients included at the preceding dose level(s) at Day 28 after infusion (end of Cycle 1) does not indicate relevant toxicity.

DRUG

TRIN2755

In treatment schedule B (Group B), the starting dose to be investigated is 800mg, given once every 7 days in a 4 week cycle. Subsequent patients can only be included on a new dose level when the safety review from all patients included at the preceding dose level(s) at Day 28 after the start of the first infusion (end of Cycle 1) does not indicate relevant toxicity.

Sponsors & Collaborators

  • University Hospital, Essen

    collaborator OTHER

  • Central European Society for Anticancer Drug Research

    collaborator OTHER

  • Assign Data Management and Biostatistics GmbH

    collaborator OTHER

  • Trin Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Max E Scheulen, PHD MD · Department of Internal Medicine West German Cancer Centre University Hospital Essen Essen, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-09-30
Completion
2012-01-31

Countries

  • Germany

Study Locations

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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 NCT01259518 on ClinicalTrials.gov