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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01574716
Other study ID # MORAb-004-203-STS
Secondary ID 2012-001399-12
Status Completed
Phase Phase 2
First received
Last updated
Start date August 7, 2012
Est. completion date August 2, 2016

Study information

Verified date November 2016
Source Morphotek
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MORAb-004
IV, Days 1 and 8 of every cycle until disease progression
Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
Docetaxel
IV, Day 8 of every cycle until disease progression
Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
Docetaxel
IV, Day 8 of every cycle until disease progression
Placebo


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Sponsors (1)

Lead Sponsor Collaborator
Morphotek

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Italy,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 2: Radiologic Progression-free Survival (PFS) PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause. From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
Secondary Part 2: Symptomatic Progression-free Survival PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause. From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)
Secondary Part 2: Overall Survival (OS) OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. From date of first dose until date of death from any cause (up to approximately 3.5 years)
Secondary Part 2: Overall Response Rate (ORR) ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. From date of first dose until disease progression (up to approximately 3.5 years)
Secondary Part 2: Radiologic Progression-free Survival Rate (PFR) Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points. Weeks 12, 24, 48 and 52
Secondary Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels Up to approximately 3 years
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