Trial · NCT03165721
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Overall Response (Complete Response or Partial Response) of SGI-11 Using the Response Evaluation Criteria in Solid Tumors (RECIST) | After the first 4 weeks, then every 8 weeks up to 65 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Distress From Baseline | Baseline, end of cycle 4, and post therapy follow up, approximately 30 days after the final dose of study drug | n=6 for the first Group at the end of cycle 4; this time data at this time point was not collected for one participant. Participant off therapy due to progressive disease (PD) at the end of cycle 1 for the third Group. | Scores on a scale | MEAN |
| POST_HOC | Progression Free Survival Probability at 6 Months | 6 months | Patient's progressed at 3.9 months and 1.1 month respectively, for the second and third groups. | Percent probability | NUMBER |
| POST_HOC | Progression Free Survival (PFS) Probability at 12 Months | 12 months | Patient's progressed at 3.9 months and 1.1 month respectively, for the second and third groups. | Percent probability | NUMBER |
| POST_HOC | Overall Survival (OS) | Time from treatment start date until date of death or date last known alive, up to approximately 3 years, 2 months. | |||
| POST_HOC | Quality of Life (QOL) Relative to Any Degree of Response (Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health) | Baseline, at the end of cycle 4, and post therapy follow up, approximately 30 days after the final dose of study drug | Participant off therapy due to progressive disease (PD) at the end of cycle 1 in the third Group. | t-score | MEAN |
| POST_HOC | Quality of Life (QOL) Relative to Any Degree of Response (Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health) | Baseline, at the end of cycle 4, and post therapy follow up, approximately 30 days after the final dose of study drug | n=6 for the first Group at the end of cycle 4; this time data at this time point was not collected for one participant. Participant off treatment at cycle 1 due to progressive disease (PD) in the third Group. | t-score | MEAN |
| POST_HOC | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approx. 1 mos and 5 days for the Gastrointestinal stromal tumor (GIST) group; 3 mos and 25 days for the Pheochromocytoma/Paraganglioma (Pheo/PGL) group;and 30 mos and 2 days for the Renal Cell Cancer group. | Participants | COUNT_OF_PARTICIPANTS | |
| POST_HOC | Maximum Observed Plasma Concentration (Cmax) of Guadecitabine (SGI-110) | Prior to first dose in cycle 1 and at 0.5 hour (+/- 15 minutes), 1 hour (+/- 15 minutes), 2 hour (+/-30 minutes), 4 hour (+/- 30 minutes), 6 hour (+/- 1 hour) and 24 hours (+/- 2 hours) after the first dose of drug in Cycle 1. | Data was analyzed together for all participants because tumor type would not be expected to impact pharmacokinetic parameters or measures of pharmacodynamics that use peripheral blood mononuclear cells (LINE-1 demethylation). | ng/mL | GEOMETRIC_MEAN |
| POST_HOC | Percent Decrease in Long Interspersed Nuclear Element -1 (LINE-1) Demethylation | Day 14 of cycle 1 | Data was analyzed together for all patients because tumor type would not be expected to impact pharmacokinetic parameters or measures of pharmacodynamics that use peripheral blood mononuclear cells (LINE-1 demethylation). | Percent decrease | MEAN |
| POST_HOC | Half Life (t1/2) of Guadecitabine (SGI-110) | Prior to first dose in cycle 1 and at 0.5 hour (+/- 15 minutes), 1 hour (+/- 15 minutes), 2 hour (+/-30 minutes), 4 hour (+/- 30 minutes), 6 hour (+/- 1 hour) and 24 hours (+/- 2 hours) after the first dose of drug in Cycle 1. | Data was analyzed together for all patients because tumor type would not be expected to impact pharmacokinetic parameters or measures of pharmacodynamics that use peripheral blood mononuclear cells (LINE-1 demethylation). | hrs | NUMBER |
| POST_HOC | Time to Maximum Observed Plasma Concentration (Tmax) of Guadecitabine (SGI-110) | Prior to first dose in cycle 1 and at 0.5 hour (+/- 15 minutes), 1 hour (+/- 15 minutes), 2 hour (+/-30 minutes), 4 hour (+/- 30 minutes), 6 hour (+/- 1 hour) and 24 hours (+/- 2 hours) after the first dose of drug in Cycle 1. | Data was analyzed together for all patients because tumor type would not be expected to impact pharmacokinetic parameters or measures of pharmacodynamics that use peripheral blood mononuclear cells (LINE-1 demethylation). | hr | MEDIAN |
| POST_HOC | Area Under the Concentration Time Curve (AUC 0-5hr) | Prior to first dose in cycle 1 and at 0.5 hour (+/- 15 minutes), 1 hour (+/- 15 minutes), 2 hour (+/-30 minutes), 4 hour (+/- 30 minutes), 6 hour (+/- 1 hour) and 24 hours (+/- 2 hours) after the first dose of drug in Cycle 1. | Data was analyzed together for all patients because tumor type would not be expected to impact pharmacokinetic parameters or measures of pharmacodynamics that use peripheral blood mononuclear cells (LINE-1 demethylation). | hr*ng/mL | GEOMETRIC_MEAN |
| POST_HOC | V(2)/F (Apparent Volume of Distribution) | Prior to first dose in cycle 1 and at 0.5 hour (+/- 15 minutes), 1 hour (+/- 15 minutes), 2 hour (+/-30 minutes), 4 hour (+/- 30 minutes), 6 hour (+/- 1 hour) and 24 hours (+/- 2 hours) after the first dose of drug in Cycle 1. | Data was analyzed together for all patients because tumor type would not be expected to impact pharmacokinetic parameters or measures of pharmacodynamics that use peripheral blood mononuclear cells (LINE-1 demethylation). | L | NUMBER |
| POST_HOC | (CL/F) Apparent Total Body Clearance | Prior to first dose in cycle 1 and at 0.5 hour (+/- 15 minutes), 1 hour (+/- 15 minutes), 2 hour (+/-30 minutes), 4 hour (+/- 30 minutes), 6 hour (+/- 1 hour) and 24 hours (+/- 2 hours) after the first dose of drug in Cycle 1. | Data was analyzed together for all patients because tumor type would not be expected to impact pharmacokinetic parameters or measures of pharmacodynamics that use peripheral blood mononuclear cells (LINE-1 demethylation). | L/hr | NUMBER |
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.
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