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

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ClinicalTrials.gov Identifier: NCT01065025
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : April 13, 2015
Sponsor:
Information provided by:
4SC AG

Tracking Information
First Submitted Date  ICMJE February 5, 2010
First Posted Date  ICMJE February 9, 2010
Last Update Posted Date April 13, 2015
Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
To investigate safety and tolerability of repeated ascending oral doses of 4SC-205 and to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT). Further, to assess the pharmacokinetics of 4SC-205. [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
  • Pharmacokinetics [ Time Frame: 6 weeks ]
  • Anti-cancer activity of 4SC-205 after 6 weeks of treatment. [ Time Frame: 6 weeks ]
  • Effects of EG5 inhibition on biomarker modulation. [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2010)
  • To evaluate optimal dose scheduling for further studies (i.e. once weekly versus twice weekly dosing). [ Time Frame: 6 weeks ]
  • To assess potential anti-cancer activity of 4SC-205 after 6 weeks of treatment by CT scanning. [ Time Frame: 6 weeks ]
  • To investigate effects of EG5 inhibition on biomarker modulation. [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label, Dose Escalation Trial of Oral Eg5 Kinesin-spindle Inhibitor 4SC-205 in Patients With Advanced Malignancies
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced and Incurable Solid Tumors
  • Malignant Lymphomas
Intervention  ICMJE Drug: 4SC-205
Repeated ascending oral doses of 4SC-205.
Study Arms  ICMJE Experimental: 4SC-205
Intervention: Drug: 4SC-205
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 15, 2014)
60
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2010)
30
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01065025
Other Study ID Numbers  ICMJE 4SC-205-1-2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE 4SC AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Klaus Mross, PD Dr. med. Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg (KTB)
PRS Account 4SC AG
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP