Open Label, Dose Escalation Trial of Oral Eg5 Kinesin-spindle Inhibitor 4SC-205 in Patients With Advanced Malignancies (AEGIS)
This study has been completed.
Sponsor:
4SC AG
Information provided by:
4SC AG
ClinicalTrials.gov Identifier:
NCT01065025
First received: February 5, 2010
Last updated: April 10, 2015
Last verified: April 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Advanced and Incurable Solid Tumors Malignant Lymphomas |
Drug: 4SC-205 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by 4SC AG:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Anti-cancer activity of 4SC-205 after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Effects of EG5 inhibition on biomarker modulation. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2010 |
| Study Completion Date: | April 2015 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 4SC-205 |
Drug: 4SC-205
Repeated ascending oral doses of 4SC-205.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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 Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065025
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065025
Locations
| Germany | |
| Universitätsklinikum Essen | |
| Essen, Germany | |
| Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB) | |
| Freiburg, Germany | |
Sponsors and Collaborators
4SC AG
Investigators
| Principal Investigator: | Klaus Mross, PD Dr. med. | Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB) |
More Information
| ClinicalTrials.gov Identifier: | NCT01065025 History of Changes |
| Other Study ID Numbers: | 4SC-205-1-2009 |
| Study First Received: | February 5, 2010 |
| Last Updated: | April 10, 2015 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by 4SC AG:
|
4SC-205 Solid tumors Lymphomas Phase I |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016