Study of IGF-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02045368|
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : May 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Brain Cancer Gastrointestinal Cancers Genitourinary Cancers Gynecologic Cancers Head and Neck Cancers Melanoma Thoracic Cancers||Drug: IGF-Methotrexate conjugate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||STM-02: Phase I Study of IGF-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R|
|Actual Study Start Date :||January 28, 2014|
|Actual Primary Completion Date :||September 30, 2016|
|Actual Study Completion Date :||September 30, 2016|
Experimental: Subject Treatment with IGF-Methotrexate conjugate
IV infusion at the assigned dose administered on days 1, 8, and 15 of a 28 day (4 week) cycle.
Drug: IGF-Methotrexate conjugate
IV infusion at the assigned dose administered on days 1, 8, and 15 of a 28 day (4 week) cycle. Up to 7 dose levels will be tested, starting with 0.05 µequivalents per kg and up to 2.5 µequivalents per kg.
Other Name: 765IGF-MTX
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 30 days after final dose. ]The primary objective is to determine the maximum tolerated dose (MTD) of 765IGF-MTX by evaluation of toxicity for the treatment of advanced, previously treated malignancies that express IGF-1R.
- Adverse Effects [ Time Frame: Up to 30 days after last dose study drug. ]Characterize adverse effects (AE) of 765IGF-MTX in patients with advanced, previously treated malignancies as defined by CTCAE v 4.0.
- Disease Response based on RECIST Criteria [ Time Frame: Up to 8 weeks after last dose study drug. ]Evaluate clinical response of 765IGF-MTX in patients with advanced, previously treated malignancies. Disease response will be assessed every 8 weeks while on study treatment using the Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045368
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Neeta Venepalli, MD||University of Illinois at Chicago|