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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT01065025
• Date of registration: 05/02/2010
• Prospective Registration: No
• Primary sponsor: 4SC AG
• Public title: Open Label, Dose Escalation Trial of Oral Eg5 Kinesin-spindle Inhibitor 4SC-205 in Patients With Advanced Malignancies AEGIS
• Scientific 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
• Date of first enrolment: January 2010
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01065025
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Klaus Mross, PD Dr. med.
• Affiliation: Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Malignant Lymphomas

Advanced and Incurable Solid Tumors

Intervention(s)

Drug: 4SC-205

Primary Outcome(s)

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 Outcome(s)

Effects of EG5 inhibition on biomarker modulation. [Time Frame: 6 weeks]

Anti-cancer activity of 4SC-205 after 6 weeks of treatment. [Time Frame: 6 weeks]

Pharmacokinetics [Time Frame: 6 weeks]

Secondary ID(s)

4SC-205-1-2009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors