A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00816400
First received: December 23, 2008
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: MEDI-575 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, a Fully Human Monoclonal Antibody Directed Against Platelet-derived Growth Factor Receptor Alpha (PDGFRα), in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists |
Resource links provided by NLM:
Further study details as provided by MedImmune LLC:
Primary Outcome Measures:
- Evaluate the safety and tolerability of MEDI-575 and to determine the maximum tolerated dose in this subject population. [ Time Frame: 30 days after the last dose of MEDI-575. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess of PK, IM, and antitumor activity. [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
- To determine the maximum tolerated dose (MTD) and/or optimal biologic does of MEDI-575 in adult subjects with advanced solid tumors. [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
| Enrollment: | 35 |
| Study Start Date: | January 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
MEDI-575 (Dose escalation and Dose Expansion Cohort)
|
Drug: MEDI-575
Administered at a dose determined by the subjects enrollment cohort as a 60 or 90 min. IV infusion as part of a 21 day treatment cycle.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed advanced solid tumor for which no curative or standard therapies exist
- Karnofsky performance status of ≥ 60
- Life expectancy of >12 weeks
- Adequate hematologic and organ function
- Negative serum pregnancy test (women only)
- Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential
Exclusion Criteria:
- Prior chemotherapy or investigational treatment within 4 weeks of study drug administration
- Prior biological or immunological treatment within 6 weeks of study drug administration
- Concurrent therapy for of cancer
- Major surgery within four weeks or minor surgery within two weeks of study drug administration
- History of diabetes or current treatment for 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
- History of other invasive malignancy within 5 years (exceptions are cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that are surgically cured)
- Significant active infection
- Known brain metastases
- Pregnancy or lactation or plans to become pregnant while on study
- Clinically significant abnormality on ECG
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816400
Locations
| United States, Colorado | |
| Research Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Indiana | |
| Research Center | |
| Indianapolis, Indiana, United States, 46219 | |
| United States, Nevada | |
| Research Site | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, Texas | |
| Research Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Virginia | |
| Research Center | |
| Norfolk, Virginia, United States, 23502 | |
Sponsors and Collaborators
MedImmune LLC
Investigators
| Study Director: | Robert Sikorski, M.D. | MedImmune LLC |
More Information
Additional Information:
No publications provided
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00816400 History of Changes |
| Other Study ID Numbers: | MI-CP187 |
| Study First Received: | December 23, 2008 |
| Last Updated: | September 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 16, 2013