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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01065025
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : April 13, 2015
Sponsor:
Information provided by:
4SC AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced and Incurable Solid Tumors Malignant Lymphomas Drug: 4SC-205 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 4SC-205 Drug: 4SC-205
Repeated ascending oral doses of 4SC-205.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065025


Locations
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Germany
Universitätsklinikum Essen
Essen, Germany
Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)
Freiburg, Germany
Sponsors and Collaborators
4SC AG
Investigators
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Principal Investigator: Klaus Mross, PD Dr. med. Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)
More Information
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ClinicalTrials.gov Identifier: NCT01065025    
Other Study ID Numbers: 4SC-205-1-2009
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015
Keywords provided by 4SC AG:
4SC-205
Solid tumors
Lymphomas
Phase I
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases