Trial · NCT02936323
PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers
NCT02936323, Phase 1, Phase 2, Completed, Tarveda Therapeutics; results first posted 2021-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers. Trials, record NCT02936323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02936323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PEN-221 in Somatostatin Receptor 2 Expressing Advanced Cancers Including Neuroendocrine and Small Cell Lung Cancers
- NCT number
- NCT02936323
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- Tarveda Therapeutics
- Conditions
- Neuroendocrine Tumors, Carcinoma, Small Cell Lung, Neuroendocrine Carcinoma
- Interventions
- PEN-221, PEN-221
- First posted
- 2016-10-18
- Last updated
- 2021-12-14
- Results first posted
- 2021-12-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | MTD was determined by testing increasing doses up to 25 mg flat dose IV over 1 hour on an every 3 week cycle on dose escalation cohorts 1 to 7 with 2 participants in cohort 1 and 3-6 participants each in cohorts 2-7. The MTD was defined as the highest drug dosage not causing a Dose Limiting Toxicity (DLT) in \> 33% of the treated participants during the first cycle of treatment. DLTs were defined as any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.03 occurring within the first 4 weeks for cohort 1 and within 3 weeks for each subsequent cohort that was not related to underlying disease, disease progression, intercurrent illness, or concomitant medications. The RP2D was established by achieving the Maximum Tolerated Dose (MTD). The RP2D may be equal to or below the MTD. |
| 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 | DLTs were defined as any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.03 occurring within the first 4 weeks for cohort 1 and within 3 weeks for each subsequent cohort that was not related to underlying disease, disease progression, intercurrent illness, or concomitant medications. Grade 3 is a severe AE and Grade 4 is a life-threatening or disabling AE. DLTs were collected to determine the Maximum-Tolerated Dose (MTD), which is defined as the dose level below the dose at which \> 33% of participants experienced a DLT during the first cycle of treatment. |
| 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). | Efficacy of PEN-221 in gastrointestinal mid-gut NETs and pancreatic NETs using clinical benefit rate (CBR) defined as the best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 using the investigator assessment. |
| 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). | Efficacy of PEN-221 in Small Cell Lung Cancer (SCLC) using objective response rate (ORR) as defined as the best overall response of CR or PR using tumor response criteria defined by RECIST 1.1. |
| 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). | Duration of Response (DOR) is defined as the time from the first documented response (CR or PR), as assessed by the investigator, to the date of first documented disease progression or death due to underlying cancer. If patient did not progress or die before the data cutoff date (31-July-2020), DOR was censored at the date of last adequate tumor assessment. |
| 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). | Phase 1 and Phase 2a participants who experienced any Treatment-Emergent Adverse Event (TEAE) to determine the safety and tolerability of PEN-221. TEAEs are any AE that occurred after first dose of study drug through 28 days after the last dose of study drug, any event considered study drug related regardless of start date of the event, or any event that was present at baseline but worsened in intensity or was subsequently considered study drug related by the Investigator. Phase 2a TEAEs were collected for reporting in the BSA dosing format only. |
| 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. | Blood samples were obtained and plasma concentrations were determined using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Phase 2a data were collected for reporting in the BSA dosing format only. |
| 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. | Blood samples were obtained and plasma concentrations were determined using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Phase 2a data were collected for reporting in the BSA dosing format only. |
| 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. | Blood samples were obtained and plasma concentrations were determined using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Phase 2a data collected for reporting in the BSA dosing format only. |
| 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). | Assess the potential of preliminary anti-tumor activity of PEN-221 using tumor response criteria as defined by RECIST 1.1. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group334
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Maximum Tolerated Dose of PEN-221 and Recommended Phase 2a Dose (RP2D) | All Participants in Phase 1 Dose Escalation (Cohorts 1-7) | 18.0 | mg | ||
| Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Phase 1 Dose Escalation (Cohort 1) | 0 | participants | ||
| Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Phase 1 Dose Escalation (Cohort 2) | 0 | participants | ||
| Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Phase 1 Dose Escalation (Cohort 3) | 0 | participants | ||
| Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Phase 1 Dose Escalation (Cohort 4) | 0 | participants | ||
| Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Phase 1 Dose Escalation (Cohort 5) | 0 | participants | ||
| Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Phase 1 Dose Escalation (Cohort 6) | 0 | participants | ||
| Phase 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) | Phase 1 Dose Escalation (Cohort 7) | 2 | participants | ||
| Phase 2a: Percentage of Gastrointestinal Mid-gut NETs and Pancreatic NETs Participants Who Achieved Clinical Benefit as Determined by RECIST 1.1 | Phase 2a Dose Expansion (GI Mid-gut NET Cohort) | 88.5 | 95% Confidence Interval 69.8 to 97.6 | percentage of participants | |
| Phase 2a: Percentage of Gastrointestinal Mid-gut NETs and Pancreatic NETs Participants Who Achieved Clinical Benefit as Determined by RECIST 1.1 | Phase 2a Dose Expansion (PNET Cohort | 50 | 95% Confidence Interval 21.1 to 78.9 | percentage of participants |
1 to 10 of 334Source ClinicalTrials.gov
See all 334 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 Dose Escalation | STARTED | Phase 1 Dose Escalation (Cohort 1) | 2 | |
| Phase 1 Dose Escalation | STARTED | Phase 1 Dose Escalation (Cohort 2) | 3 | |
| Phase 1 Dose Escalation | STARTED | Phase 1 Dose Escalation (Cohort 3) | 3 | |
| Phase 1 Dose Escalation | STARTED | Phase 1 Dose Escalation (Cohort 4) | 3 | |
| Phase 1 Dose Escalation | STARTED | Phase 1 Dose Escalation (Cohort 5) | 3 | |
| Phase 1 Dose Escalation | STARTED | Phase 1 Dose Escalation (Cohort 6) | 6 | |
| Phase 1 Dose Escalation | STARTED | Phase 1 Dose Escalation (Cohort 7) | 3 | |
| Phase 1 Dose Escalation | STARTED | Phase 2a Dose Expansion (GI Mid-gut NET Cohort) | 0 | |
| Phase 1 Dose Escalation | STARTED | Phase 2a Dose Expansion (PNET Cohort) | 0 | |
| Phase 1 Dose Escalation | STARTED | Phase 2a Dose Expansion (SCLC Cohort) | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events2,610
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Phase 1 Dose Escalation (Cohort 1) | 1 | 2 | 1 |
| other | Nausea | Gastrointestinal disorders | Phase 1 Dose Escalation (Cohort 2) | 3 | 3 | 9 |
| other | Nausea | Gastrointestinal disorders | Phase 1 Dose Escalation (Cohort 3) | 1 | 3 | 1 |
| other | Nausea | Gastrointestinal disorders | Phase 1 Dose Escalation (Cohort 4) | 1 | 3 | 2 |
| other | Nausea | Gastrointestinal disorders | Phase 1 Dose Escalation (Cohort 5) | 2 | 3 | 4 |
| other | Nausea | Gastrointestinal disorders | Phase 1 Dose Escalation (Cohort 6) | 5 | 6 | 10 |
| other | Nausea | Gastrointestinal disorders | Phase 1 Dose Escalation (Cohort 7) | 2 | 3 | 2 |
| other | Nausea | Gastrointestinal disorders | Phase 2a Dose Expansion (<8.8 mg/m^2) | 6 | 12 | 7 |
| other | Nausea | Gastrointestinal disorders | Phase 2a Dose Expansion (8.8 mg/m^2) | 16 | 34 | 21 |
| other | Nausea | Gastrointestinal disorders | Phase 2a Dose Expansion (>8.8 mg/m^2) | 10 | 20 | 17 |
1 to 10 of 2,610Source ClinicalTrials.gov
See all 2,610 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Dose Escalation (Cohort 1) | 2 | 2 |
| Total, all-cause mortality | Phase 1 Dose Escalation (Cohort 2) | 1 | 3 |
| Total, all-cause mortality | Phase 1 Dose Escalation (Cohort 3) | 3 | 3 |
| Total, all-cause mortality | Phase 1 Dose Escalation (Cohort 4) | 1 | 3 |
| Total, all-cause mortality | Phase 1 Dose Escalation (Cohort 5) | 2 | 3 |
| Total, all-cause mortality | Phase 1 Dose Escalation (Cohort 6) | 3 | 6 |
| Total, all-cause mortality | Phase 1 Dose Escalation (Cohort 7) | 3 | 3 |
| Total, all-cause mortality | Phase 2a Dose Expansion (<8.8 mg/m^2) | 4 | 12 |
| Total, all-cause mortality | Phase 2a Dose Expansion (8.8 mg/m^2) | 8 | 34 |
| Total, all-cause mortality | Phase 2a Dose Expansion (>8.8 mg/m^2) | 10 | 20 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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