Dose Escalation Study of TriN2755 in Advanced Solid Tumors and Sarcomas

NCT01259518 | Unknown Phase 1 DMC

• 1 other identifier: TRIN2755-I-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  at baseline and beginning of every cycle

Secondary Outcomes (5)

• Objective response rate (ORR); RECIST v1.0 Criteria

  3 Years

• Progression free survival (PFS)

  3 years

• Overall survival (OS) within 12 months after the first infusion of TriN 2755

  12 months

• Pharmacokinetics of TRIN2755 and its metabolites

  4 weeks

• Concentration of DNA methyl adducts in leucocytes and urine, analysis of DNA strand breaks

  4 weeks

Study Arms (2)

Once monthly administration of TRIN2755

EXPERIMENTAL

Drug: TRIN2755

Once weekly administration of TRIN2755

EXPERIMENTAL

Drug: TRIN2755

Interventions

TRIN2755 DRUG

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.

Once monthly administration of TRIN2755

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients of age \> 18 years
• Patients with a histologically / cytologically confirmed diagnosis of advanced solid tumor or sarcoma for which a treatment of proven efficacy does not exist or an established treatment(s) had failed
• Measurable or non-measurable disease according to RECIST v1.0 criteria. Patients should have at least one measurable lesion or disease which is non-measurable but can clearly be evaluated for response
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Life expectancy of at least 3 months
• Ability to understand the nature of the study and willingness to sign a written informed consent document
• Willingness and ability to comply with the study protocol for the duration of the study

You may not qualify if:

• Any lymphoma or other hematological tumors
• Known brain metastases
• Earlier history of other tumors, except non melanoma-skin cancer or in situ cervical carcinoma curatively excised
• Major surgery within 4 weeks prior to treatment start
• Extensive radiotherapy, within 2 weeks of treatment start, or cytotoxic chemotherapy or limited radiotherapy within 2 weeks of treatment start
• Unresolved toxicity from prior chemotherapy (including approved and experimental drugs)
• Any of the following abnormal baseline hematological values:
• Hb \< 10g/dl,
• WBC \< 3.0 x 109/l Neutrophils \< 1.5 x 109/l
• Platelets \< 100 x 109/l
• Any of the following abnormal baseline liver function tests:
• Serum bilirubin \> 1.5 x upper normal limit, \> 3 x if due to tumor
• ALAT and/or ASAT \> 2.5 x upper normal limit, \> 5 x if due to tumor
• The following abnormal baseline renal function test:
• Serum creatinine \> 1.5 mg/dl

Sponsors & Collaborators

• Trin Therapeutics GmbH: lead
• University Hospital, Essen: collaborator
• Central European Society for Anticancer Drug Research: collaborator
• Assign Data Management and Biostatistics GmbH: collaborator

Study Sites (1)

Department of Internal Medicine West German Cancer Centre University Hospital Essen

Essen, 45122, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Max E Scheulen, PHD MD

  Department of Internal Medicine West German Cancer Centre University Hospital Essen Essen, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max E. Scheulen, PhD/MD

CONTACT

+49 201 723; cordula.derks@uk-essen.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: December 14, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

DE (1)