Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients
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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: NCT02568046 |
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Recruitment Status :
Terminated
(Discontinued development of Sym004 in combination with FOLFIRI)
First Posted : October 5, 2015
Results First Posted : January 9, 2019
Last Update Posted : March 26, 2019
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Sponsor:
Symphogen A/S
Information provided by (Responsible Party):
Symphogen A/S
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Metastatic Colorectal Cancer |
| Interventions |
Drug: Sym004 Drug: FOLFIRI |
| Enrollment | 10 |
Participant Flow
| Recruitment Details | The first patient was enrolled in March 2016. In January 2017, the trial was terminated early and enrollment was prematurely discontinued. |
| Pre-assignment Details |
Baseline Characteristics
Outcome Measures
Adverse Events
Limitations and Caveats
The trial was terminated as development of Sym004 in combination with FOLFIRI was discontinued. The primary objective changed to assess the safety of the treatment combination; collection of data for secondary and exploratory objectives was omitted.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Publications shall not disclose any Sponsor confidential information and property (not including the trial results). The Sponsor reserves the right to review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title: | Chief Scientific Officer |
| Organization: | Symphogen A/S |
| Phone: | +45 8838 2600 |
| EMail: | info@symphogen.com |
| Responsible Party: | Symphogen A/S |
| ClinicalTrials.gov Identifier: | NCT02568046 History of Changes |
| Other Study ID Numbers: |
Sym004-09 2015-003047-19 ( EudraCT Number ) |
| First Submitted: | September 30, 2015 |
| First Posted: | October 5, 2015 |
| Results First Submitted: | December 19, 2018 |
| Results First Posted: | January 9, 2019 |
| Last Update Posted: | March 26, 2019 |