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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
4SC AG
ClinicalTrials.gov Identifier:
NCT01065025
First received: February 5, 2010
Last updated: August 12, 2014
Last verified: August 2014
  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
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided

ClinicalTrials.gov Identifier: NCT01065025     History of Changes
Other Study ID Numbers: 4SC-205-1-2009
Study First Received: February 5, 2010
Last Updated: August 12, 2014
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 22, 2014