Trial · NCT02936323
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Maximum Tolerated Dose of PEN-221 and Recommended Phase 2a Dose (RP2D) | Up to 4 weeks in the first cohort and up to 3 weeks for each subsequent cohort | All Phase 1 participants who received at least one dose of PEN-221 and either experienced a DLT or had been followed for the full DLT evaluation period. | mg | NUMBER |
| PRIMARY | Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Up to 4 weeks in the first cohort and up to 3 weeks for each subsequent cohort | All Phase 1 participants who received at least one dose of PEN-221 and either experienced a DLT or had been followed for the full DLT evaluation period. | participants | NUMBER |
| PRIMARY | Phase 2a: Percentage of Gastrointestinal Mid-gut NETs and Pancreatic NETs Participants Who Achieved Clinical Benefit as Determined by RECIST 1.1 | Baseline and every 9 weeks up to time of disease progression (per RECIST 1.1) or death, up to data cut-off (31 Jul 2020). | Outcome measured by cancer type. GI mid-gut NET or PNET participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment. | percentage of participants | NUMBER |
| PRIMARY | Phase 2a: Number of Small Cell Lung Cancer (SCLC) Participants Who Achieved an Objective Response of Complete Response (CR) or Partial Response (PR) as Defined by RECIST 1.1. | Baseline and every 6 weeks up to time of disease progression (per RECIST 1.1) or death, up to data cut-off (31 Jul 2020). | Outcome measured by cancer type. SCLC participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2a: Duration of Response (DOR) for Small Cell Lung Cancer (SCLC) | From the date of first treatment through the date of first documented progression, assessed up to data cut-off (31 Jul 2020). | Outcome measured by cancer type. SCLC participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment. No participants in the SCLC cohort had an objective response, so no data is presented for this Outcome Measure. | ||
| SECONDARY | Number of Study Participants Who Experienced Treatment-Emergent Adverse Events | From date of first treatment/trial entry until 28 days after last treatment for each participant, up to data cut-off (31 Jul 2020). | The Safety Analysis population was comprised of all enrolled participants who received any amount of study drug and had at least 1 post-baseline safety evaluation. All non-BSA based doses in Phase 2a were converted to BSA dosing units.~Participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Concentration (Cmax) of PEN-221, DM1, and Peptide | Phase 1: Day 1 of Cycles 1 and 3 pre-start of infusion (SOI), at 0.5, 1, 1.5, 2, 4, 6, 8, 10 hours post-start of infusion. Phase 2a: Day 1 Cycle 1 pre-start of infusion, at 0.5,1, 1.5, 2, 4, 6, 8, 24 hours post-SOI; once at Day 8 Cycle 1. | The Pharmacokinetic Analysis set comprises all participants who received any amount of study drug and provided adequate PK samples.~Phase 2a participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose. | ng/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC) of PEN-221, DM1, and Peptide | Phase 1: Day 1 of Cycles 1 and 3 pre-start of infusion (SOI), at 0.5, 1, 1.5, 2, 4, 6, 8, 10 hours post-start of infusion. Phase 2a: Day 1 Cycle 1 pre-start of infusion, at 0.5,1, 1.5, 2, 4, 6, 8, 24 hours post-SOI; once at Day 8 Cycle 1. | The Pharmacokinetic Analysis set comprises all participants who received any amount of study drug and provided adequate PK samples.~Phase 2a participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose. | (ng/mL)*h | MEAN |
| SECONDARY | Half-life (t1/2) of PEN-221, DM1, and Peptide | Phase 1: Day 1 of Cycles 1 and 3 pre-start of infusion (SOI), at 0.5, 1, 1.5, 2, 4, 6, 8, 10 hours post-start of infusion. Phase 2a: Day 1 Cycle 1 pre-start of infusion, at 0.5,1, 1.5, 2, 4, 6, 8, 24 hours post-SOI; once at Day 8 Cycle 1. | The Pharmacokinetic Analysis set comprises all participants who received any amount of study drug and provided adequate PK samples. Phase 2a participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose. | hours | MEDIAN |
| SECONDARY | Phase 1: Number of Participants With a Best Response of an Objective Response, Stable Disease, or Progressive Disease. | Baseline, every 6 or 9 weeks depending on the tumor type, up to time of disease progression (per RECIST 1.1) or death, up to data cut-off (31 Jul 2020). | Phase 1 participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2a: Maximum Tolerated Dose (MTD) and Recommended Phase 2a Dose (RP2D) Based on Body Surface Area | From date of first treatment/trial entry until 28 days after last treatment for each Phase 2a participant, up to data cut-off (31 Jul 2020) | All Phase 2a participants who received any amount of study drug and had at least 1 post-baseline safety evaluation. SRC reviewed all Phase 1 and 31 Phase 2a participants and changed flat dose (mg) to Body Surface Area (BSA) based dose of 8.8 mg/m\^2 due to correlation between BSA and drug exposure associated with higher rate of participant discontinuation. Calculated BSA capped at 2.0 m\^2 so not to exceed Phase 1 MTD of 18 mg. Phase 2a data collected for reporting in the BSA dosing format only. | mg/m^2 | NUMBER |
| SECONDARY | Phase 2a: Progression Free Survival (PFS) | From date of first treatment/trial entry until first documented progression or date of death from any cause, whichever came first, assessed up to data cutoff of 31 Jul 2020 | Outcome measured by cancer type. GI mid-gut NET, PNET, and SCLC participants enrolled into the study and who received any amount of study drug. | Months | MEDIAN |
| SECONDARY | Phase 2a: Overall Survival (OS) | For each GI mid-gut NET, PNET, and SCLC, from date of first treatment/trial entry until the date of death from any cause, assessed up to data cutoff of 31 Jul 2020 | Outcome measured by cancer type. GI mid-gut NET, PNET, and SCLC patients enrolled into the study and who received any amount of study drug. | Months | MEDIAN |
| SECONDARY | Phase 2a: ORR for Gastrointestinal Mid-gut NETs (GI Mid-gut NET) and Pancreatic NETs (PNET) | For each GI mid-gut NET and PNET participant from the date of first treatment through the date of first documented progression, assessed up to data cutoff 31 Jul 2020 | Outcome measured by cancer type. GI mid-gut NET and PNET participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment (RECIST 1.1). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2a: Duration of Response (DOR) for Gastrointestinal Mid-gut NETs (GI Mid-gut NET) and Pancreatic NETs (PNET) | For each GI mid-gut NET and PNET participant, from the date of first treatment through the date of first documented progression, assessed up to data cutoff (31 Jul 2020) | Outcome measured by cancer type. GI mid-gut NET cohort and PNET cohort participants who received any amount of study drug and had at least 1 post-baseline efficacy assessment (RECIST 1.1). No participants in the GI mid-gut NET cohort or PNET cohort had an objective response, so no data is presented for this Outcome Measure | ||
| SECONDARY | Anti-PEN-221 Antibodies (ADA) | Baseline and every 6 weeks up to end of treatment for each patient. | All participants who received any dose of study drug with at least 1 post-baseline immunogenicity assessment. Phase 2a participants dosed under the initial MTD dosing regimen were assigned to the \< 8.8 mg/m\^2 or \> 8.8 mg/m\^2 dose groups based on the BSA conversion of the initial study dose. | Participants | COUNT_OF_PARTICIPANTS |
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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