NCT01065025

Brief Summary

The purpose of the study is to investigate safety and tolerability of repeated ascending oral doses of 4SC-205 in patients with advanced and incurable solid tumors or malignant lymphomas.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

5.2 years

First QC Date

February 5, 2010

Last Update Submit

April 10, 2015

Conditions

Advanced and Incurable Solid TumorsMalignant Lymphomas

Keywords

4SC-205Solid tumorsLymphomasPhase I

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of repeated ascending oral doses of 4SC-205. Determination of the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT).

    6 weeks

Secondary Outcomes (3)

  • Pharmacokinetics

    6 weeks

  • Anti-cancer activity of 4SC-205 after 6 weeks of treatment.

    6 weeks

  • Effects of EG5 inhibition on biomarker modulation.

    6 weeks

Study Arms (1)

4SC-205

EXPERIMENTAL
Drug: 4SC-205

Interventions

4SC-205DRUG

Repeated ascending oral doses of 4SC-205.

4SC-205

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One or more evaluable target lesion according to RECIST (by CT-scan, MRI or calipers), of which at least one evaluable target lesion (proven by CT or MRI) has to be located in the lung.
  • Progressive disease as defined by new or progressive lesions on CT-scan, MRI, bone scan or by increase of PSA.
  • Histologically or cytologically documented diagnosis of primary or metastatic solid tumors or malignant lymphomas refractory to prior standard therapy or for which no standard therapy exists. Entry will include, but is not limited to patients with prostate and breast cancer refractory to hormone treatment, ovarian cancer, head and neck cancer, non-small cell lung cancer, bladder cancer, colorectal cancer, kidney cancer, malignant melanoma or malignant lymphoma. Patients who have refused standard therapies are also eligible.
  • ECOG Performance Status 0-2.
  • Acceptable liver, renal and bone marrow function.

You may not qualify if:

  • Prior treatment with other EG5 inhibitors.
  • Antineoplastic therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 2 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin C or nitrosourea). Patients must have recovered from any treatment-related toxicity (except for alopecia, fatigue and grade 1 neurotoxicity) prior to registration.
  • Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current PSA \< 0.1 ng/ml; or cervical intraepithelial neoplasia.
  • Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness.
  • Patients with a history of, who were treated for, or who are suspected of having, hepatitis B, hepatitis C or HIV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Essen

Essen, Germany

Location

Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Klaus Mross, PD Dr. med.

    Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 9, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

DE(2)