Trial · NCT01761240
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | First dose of study drug (Baseline) up to 30 days after last dose of study drug (Up to approximately 2 years 7 months) | Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, urine values, and vital signs; periodic measurement of electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) assessments; and performance of physical examinations. |
| Secondary | Number of Participants With Dose Limiting Toxicity (DLT) | Cycle 1 (Cycle length=28 days) | DLT was defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade. |
| Secondary | Maximum Tolerated Dose (MTD) | Cycle 1 (Cycle length=28 days) | The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade. |
| Secondary | Cmax: Maximum Observed Serum Concentration for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | Tmax: Time to Reach Maximum Serum Concentration for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | t1/2: Terminal Elimination Phase Half-Life for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | AUC(0-t): Area Under the Serum Concentration-time Curve From Zero Time to the Last Measurable Point for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | AUC(0-Inf): Area Under the Serum Concentration-time Curve From Zero to Infinity for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | Vd: Volume of Distribution for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | CL: Total Body Clearance for MORAb-066 | Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days) | |
| Secondary | Number of Participants With Best Overall Response (BOR) | Up to approximately 2 years 7 months | BOR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target and non-target lesions is complete response (CR) or partial response (PR). CR: disappearance of target and non-target lesions, normalization of tumor marker level, all lymph nodes must be non-pathological in size (less than 10 millimeter \[mm\] short axis). PR: at least 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Number of Participants Positive for Antidrug Antibodies (ADA) | Up to approximately 2 years 7 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01761240/registered