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

Malignant Lymphomas Clinical Trial

— AEGIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065025
• Other study ID #: 4SC-205-1-2009
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2010
• Last updated: April 10, 2015
• Start date: January 2010
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: 4SC AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced and Incurable Solid Tumors
• Lymphoma
• Malignant Lymphomas

Intervention

Drug:
• 4SC-205
Repeated ascending oral doses of 4SC-205.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Essen	Essen
Germany	Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
4SC AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetics		6 weeks	Yes
Secondary	Anti-cancer activity of 4SC-205 after 6 weeks of treatment.		6 weeks	No
Secondary	Effects of EG5 inhibition on biomarker modulation.		6 weeks	No