ClinicalTrials.gg
CompletedNCT01065025AEGISUpdated Apr 13, 2015

Open Label, Dose Escalation Trial of Oral Eg5 Kinesin-spindle Inhibitor 4SC-205 in Patients With Advanced Malignancies

A Phase 1 interventional study of 4SC-205 in Advanced and Incurable Solid Tumors and Malignant Lymphomas, sponsored by 4SC AG. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-13.

Sponsored by 4SC AG · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 144 studies in Lymphoma with a site in Germany — 15 open to participants now, 25 under way, 8 of them phase 3. Lymphoma · Germany.

Planned enrollment
88th of 130
60 · median 114
Started
2010
with 5 others
Phase 1
19 of 144
1 open now
Registered
57th of 144
by date

Among the 144 studies in Lymphoma with a site in Germany, this one is the 88th largest by planned enrollment of the 130 interventional ones that give a count, is one of 6 that started in 2010, is one of 19 in phase 1, and was the 57th registered.

Lymphoma

3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.

Browse Lymphoma studies →

Open to participants now

15 of the 144 studies in Lymphoma with a site in Germany are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 347 Lymphoma studies recruiting now, 227 (65%) set no upper age limit and 79 (23%) stop at 75 or younger; 78 take children under 18; 20 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Advanced and Incurable Solid Tumors
  • Malignant Lymphomas

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Keywords

  • 4SC-205
  • Solid tumors
  • Lymphomas
  • Phase I
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  • One or more evaluable target lesion according to (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.
  • or cytologically documented diagnosis of primary or solid tumors or malignant lymphomas 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.
  • Performance Status 0-2.
  • Acceptable liver, renal and bone marrow function.

Main Exclusion Criteria:

  • Prior treatment with other EG5 inhibitors.
  • Antineoplastic therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other 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 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, , or .
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    4SC-205

    Drug: 4SC-205

Interventions

  • Drug4SC-205

    Repeated ascending oral doses of 4SC-205.

06

What researchers measure

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).

    Time frame: 6 weeks

Secondary outcomes

  1. Pharmacokinetics

    Time frame: 6 weeks

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

    Time frame: 6 weeks

  3. Effects of EG5 inhibition on biomarker modulation.

    Time frame: 6 weeks

07

Study locations

2 sites
  • Universitätsklinikum Essen
    Essen, Germany
  • Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)
    Freiburg, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2010
First posted
Feb 9, 2010
Start
Jan 2010
Primary completionActual
Apr 2015
CompletionActual
Apr 2015
Last update
Apr 13, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01065025
Lead sponsor
4SC AG
First posted
Feb 9, 2010
Start date
Jan 2010
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Apr 13, 2015

Study contacts

Klaus Mross, PD Dr. med.
principal investigator · Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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