A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00816361
First received: December 23, 2008
Last updated: January 6, 2014
Last verified: January 2014

December 23, 2008
January 6, 2014
March 2009
September 2012   (final data collection date for primary outcome measure)
Evaluate the safety and tolerability of MEDI-573 and to determine the MTD and/or optimal biological dose of MEDI-573 in this subject population. [ Time Frame: 30 days after patient's final dose of study drug ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00816361 on ClinicalTrials.gov Archive Site
Include assessments of PK, IM, pharmacodynamic, and antitumor activity of MEDI-573. [ Time Frame: 30 days after last dose of study drug/per subject ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists

Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: MEDI-573
Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle.
Experimental: 1
MEDI-573 - (Dose escalation Cohort)
Intervention: Drug: MEDI-573
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed advanced solid tumor for which no curative or standard therapies exist.
  • Karnofsky Performance Status ≥60.
  • Adequate hematological function.
  • Adequate organ function.
  • Women of non-child-bearing potential (defined as being >1 year post-menopausal) or using effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the investigational product may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of MEDI-573. Male subjects with partners of child-bearing potential must be surgically sterile or use contraceptive method as described above from the time of the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.

Exclusion Criteria:

  • No prior treatment within 4 weeks of study drug administration.
  • No concurrent therapy for treatment of cancer.
  • No uncontrolled diabetes.
  • New York Heart Association Grade ≥ 2 congestive heart failure.
  • History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry.
  • Documented brain metastasis.
  • Pregnancy or lactation or plans to become pregnant while on study.
  • Clinically significant abnormality on ECG.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816361
MI-CP184
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Susan Perez, MD, MSc MedImmune LLC
MedImmune LLC
January 2014

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