Clinical trial NCT01065025: Open Label, Dose Escalation Trial of Oral Eg5 Kinesin-spindle Inhibitor 4SC-205 in Patients With Advanced Malignancies
Official title: Open Label, Dose Escalation Trial of Oral 4SC-205 in Patients With Advanced Malignancies: First-In-Man Study of a Newly Developed, Oral Inhibitor of Kinesin-spindle Protein, Eg5
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced and Incurable Solid Tumors
Malignant Lymphomas
Keywords: 4SC-205
Solid tumors
Lymphomas
Phase I
Lead sponsor: 4SC AG
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Main Inclusion Criteria:

* 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.

Main Exclusion Criteria:

* 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.

Primary outcomes:
measure: Safety and tolerability of repeated ascending oral doses of 4SC-205. Determination of the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT).
timeFrame: 6 weeks
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 6 weeks
measure: Anti-cancer activity of 4SC-205 after 6 weeks of treatment.
timeFrame: 6 weeks
measure: Effects of EG5 inhibition on biomarker modulation.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)
Study officials:
affiliation: Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)
name: Klaus Mross, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: