Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-03 @ 6:29 PM
Study NCT ID:
NCT02574858
Status:
COMPLETED
Last Update Posted:
2018-01-02
First Post:
2015-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Safety of QRH-882260 Heptapeptide
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kturgeon@med.umich.edu', 'phone': '734-764-6860', 'title': 'Dr. D. Kim Turgeon', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'QRH-886620', 'description': 'The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration).\n\nQRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevated creatinine level', 'notes': 'Elevated creatinine level at visit 2 of 20%. Subject returned to submit another sample for repeat testing. Creatinine level returned to within 20% of baseline.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Abnormal Lab Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QRH-886620', 'description': 'The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration).\n\nQRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': "Review of laboratory values for abnormalities after intervention with QRH-882260. If the first post-procedure labs are outside normal range, they must be within 20% of the subject's baseline lab values or returning towards normal range. Lab values not meeting these criteria must be repeated weekly until they peak and weekly until normal or within 20% of baseline level or within normal range.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Abnormal EKG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'QRH-886620', 'description': 'The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration).\n\nQRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': 'Review of EKG for abnormalities after intervention with QRH-882260. Paired EKGs will be reviewed for electrical changes post QRH-882260 ingestion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QRH-886620', 'description': 'The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration).\n\nQRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'QRH-886620', 'description': 'The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration).\n\nQRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Ages of Participants', 'categories': [{'title': '22-29 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '30-39 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '40-49 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '50-59 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '60-69 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-05', 'studyFirstSubmitDate': '2015-10-07', 'resultsFirstSubmitDate': '2017-07-12', 'studyFirstSubmitQcDate': '2015-10-09', 'lastUpdatePostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-12', 'studyFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Abnormal Lab Values', 'timeFrame': '48 hours', 'description': "Review of laboratory values for abnormalities after intervention with QRH-882260. If the first post-procedure labs are outside normal range, they must be within 20% of the subject's baseline lab values or returning towards normal range. Lab values not meeting these criteria must be repeated weekly until they peak and weekly until normal or within 20% of baseline level or within normal range."}, {'measure': 'Number of Subjects With Abnormal EKG', 'timeFrame': '30 minutes', 'description': 'Review of EKG for abnormalities after intervention with QRH-882260. Paired EKGs will be reviewed for electrical changes post QRH-882260 ingestion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of orally administered QRH-882260, a topically administered Cy5-labeled heptapeptide specific for epithelial growth factor receptor (EGFR).', 'detailedDescription': 'This is a Phase IA study of the safety of an orally administered QRH-882260 heptapeptide for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 10 evaluable subjects. The investigators expect to be able to enroll about 1-2 subjects per week, so the study should take about 1-2 months to complete.\n\nInterested, healthy subjects ages 25-100 who respond to recruitment advertising and appear to be eligible based on a screening questionnaire will be scheduled for a study visit at MCRU. At the study visit, the subjects will review and sign the informed consent and eligibility will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a urine sample for urinalysis. A baseline EKG will be recorded. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted QRH-882260 heptapeptide. After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water. Subjects will remain in MCRU for observation for 30 minutes. Vital signs and an EKG will be recorded after 30 minutes. Subjects are required to have repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after QRH-882260 heptapeptide ingestion. The study team will conduct a follow up phone call to verbally assess toxicity after post-ingestion labs (within 7 days).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Adults age 25 to 100 years\n* Not pregnant (willing to have pregnancy test if applicable)\n* No recent illness (infection, URI, virus or flu) within 2 weeks,\n* Stable health status (i.e. no medication changes within 2 months, no recent surgery, etc. per PI)\n* Willing and able to sign informed consent\n* Willing and able to drink the peptide and a tap water chaser\n* Willing and able to get baseline and 24-48 hours post ingestion labs Exclusion Criteria\n* Known allergy to Cy5 or derivatives, such as indocyanine green (ICG)\n* Subjects on active chemotherapy or radiation therapy\n* Diabetics on insulin/hypoglycemic (due to fasting requirements)'}, 'identificationModule': {'nctId': 'NCT02574858', 'acronym': 'QRH-882260', 'briefTitle': 'Study of the Safety of QRH-882260 Heptapeptide', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'orgStudyIdInfo': {'id': 'HUM00099903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QRH-886620', 'description': 'The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\\~100 µM concentration).', 'interventionNames': ['Drug: QRH-882260']}], 'interventions': [{'name': 'QRH-882260', 'type': 'DRUG', 'description': 'The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.', 'armGroupLabels': ['QRH-886620']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine', 'investigatorFullName': 'Danielle Kim Turgeon', 'investigatorAffiliation': 'University of Michigan'}}}}