Trial · NCT04209595
PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers
NCT04209595, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2024-01-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers. Trials, record NCT04209595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04209595
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers
- NCT number
- NCT04209595
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Small Cell Lung Cancer, Extra-Pulmonary Small Cell Carcinomas
- Interventions
- PLX038, Rucaparib, Ondansetron
- First posted
- 2019-12-24
- Last updated
- 2026-08-26
- Results first posted
- 2024-01-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase II: Clinical Benefit Rate | Disease progression at 4 months | Assess the efficacy with respect to clinical benefit rate (CBR) (Complete Response (CR)+ partial response (PR)+ stable disease (SD) for 4 months according to Response Evaluation Criteria (RECIST 1.1) of a combination of PLX038(PEGylated SN38) and rucaparib in previously treated participants with small cell lung cancer and extra-pulmonary small cell carcinomas. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. |
| Primary | Phase I: Maximum Tolerated Dose (MTD) of PLX038 (PEGylated SN38) in Combination With Rucaparib | One cycle, approximately 21 (+7) days | Maximum tolerated dose (MTD) of PLX038 (PEGylated SN38) in combination with rucaparib. The MTD is the dose level at which no more than 1 of 6 participants experience dose limiting toxicity (DLT) during the DLT evaluation period, and the dose below that at which at least 2 (of 6) participants have DLT as a result of the drug. A DLT is (if deemed drug-related) a Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated with hemorrhage; Grade 4 anemia that does not resolve within 7 days despite optimal therapy; Inability to begin subsequent treatment course within 21 days of the scheduled date, due to study drug toxicity. |
| Secondary | Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib | Date first signed consent to date off study, approximately 21 months and 18 days; and 2 months and 5 days for each group respectively. | The safety of the treatment will be monitored, and any toxicities identified will be reported by type and grade. Toxicities were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. |
| Secondary | Phase IIA Progression-free Survival (PFS) | Time from the on-study date to documented evidence of disease progression | Among participants in the phase IIA cohort, median progression free survival (PFS) will be calculated from the on-study date using the Kaplan-Meier method, along with 95% confidence intervals on the median PFS. PFS is defined as the time from on-study date to documented evidence of disease progression. Disease progression was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And appearance of one or more new lesions. |
| Secondary | Phase IIA Overall Survival | Date of on-study to the date of death from any cause or last follow-up | Among participants in the phase IIA cohort, median overall survival (OS) will be calculated from the on-study date using the Kaplan-Meier method, along with 95% confidence intervals on the median OS.OS is defined as the date of on-study to the date of death from any cause or last follow-up. |
| Secondary | Phase I - Number of Participants Who Experience a Clinical Response (Complete Response (CR)+Partial Response (PR) | Disease progression, a median of 43 days with range of 20 to 350 days. | The number of participants who experience a clinical response (Complete Response (CR)+Partial Response (PR) will be reported. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions; any pathological lymph nodes must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| Other | Phase I Number of Participants With a Dose Limiting Toxicity (DLT) | One cycle, approximately 21 days | A DLT is (if deemed drug-related) Grade 4 neutropenia that does not resolve within 7 days; Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated with hemorrhage; Grade 4 anemia that does not resolve within 7 days despite optimal therapy; Inability to begin subsequent treatment course within 21 days of the scheduled date, due to study drug toxicity. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date first signed consent to date off study, approximately 21 months and 18 days; and 2 months and 5 days for each group respectively. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase II: Clinical Benefit Rate | Disease progression at 4 months | This outcome measure was not done because the study was closed to enrollment due to Clovis Oncology withdrawing support for the study. No data was collected for this phase II outcome measure. | ||
| PRIMARY | Phase I: Maximum Tolerated Dose (MTD) of PLX038 (PEGylated SN38) in Combination With Rucaparib | One cycle, approximately 21 (+7) days | g/m^2 | NUMBER | |
| SECONDARY | Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib | Date first signed consent to date off study, approximately 21 months and 18 days; and 2 months and 5 days for each group respectively. | Data is reported for the phase I portion only because the study was closed to enrollment prior to phase II due to Clovis Oncology withdrawing support for the study. | Adverse events | NUMBER |
| SECONDARY | Phase IIA Progression-free Survival (PFS) | Time from the on-study date to documented evidence of disease progression | This outcome measure was not done because the study was closed to enrollment due to Clovis Oncology withdrawing support for the study. No data was collected for this phase IIA outcome measure. | ||
| SECONDARY | Phase IIA Overall Survival | Date of on-study to the date of death from any cause or last follow-up | This outcome measure was not done because the study was closed to enrollment due to Clovis Oncology withdrawing support for the study. No data was collected for this phase IIA outcome measure. | ||
| SECONDARY | Phase I - Number of Participants Who Experience a Clinical Response (Complete Response (CR)+Partial Response (PR) | Disease progression, a median of 43 days with range of 20 to 350 days. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Phase I Number of Participants With a Dose Limiting Toxicity (DLT) | One cycle, approximately 21 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date first signed consent to date off study, approximately 21 months and 18 days; and 2 months and 5 days for each group respectively. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group249
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase II: Clinical Benefit Rate | Group not reported | Complete Response | |||
| Phase II: Clinical Benefit Rate | Group not reported | Partial Response | |||
| Phase II: Clinical Benefit Rate | Group not reported | Stable Disease | |||
| Phase II: Clinical Benefit Rate | Group not reported | Progressive Disease | |||
| Phase I: Maximum Tolerated Dose (MTD) of PLX038 (PEGylated SN38) in Combination With Rucaparib | Phase I: All Participants | NA | g/m^2 | ||
| Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib | Phase I Arm 1 Level 1 - Related to PLX038 (PEGylated SN38) | Grade 1 Non-Serious Abdominal pain | 2 | Adverse events | |
| Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib | Phase I - Arm 1 Level 1A - Related to PLX038 (PEGylated SN38) | Grade 1 Non-Serious Abdominal pain | 1 | Adverse events | |
| Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib | Phase I Arm 1 Level 1 - Related to Rucaparib | Grade 1 Non-Serious Abdominal pain | 4 | Adverse events | |
| Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib | Phase I - Arm 1 Level 1A - Related to Rucaparib | Grade 1 Non-Serious Abdominal pain | 2 | Adverse events | |
| Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib | Phase I Arm 1 Level 1 - Related to PLX038 (PEGylated SN38) | Grade 1 Non-Serious Alanine aminotransferase increased | 0 | Adverse events |
1 to 10 of 249Source ClinicalTrials.gov
See all 249 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I - Maximum Tolerated Dose | STARTED | Phase I Arm 1 Level -1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 200 mg | 0 | |
| Phase I - Maximum Tolerated Dose | STARTED | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 8 | |
| Phase I - Maximum Tolerated Dose | STARTED | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 2 | |
| Phase I - Maximum Tolerated Dose | STARTED | Phase IIA Arm 2 | 0 | |
| Phase I - Maximum Tolerated Dose | STARTED | Phase IIB Arm 2 | 0 | |
| Phase I - Maximum Tolerated Dose | COMPLETED | Phase I Arm 1 Level -1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 200 mg | 0 | |
| Phase I - Maximum Tolerated Dose | COMPLETED | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 8 | |
| Phase I - Maximum Tolerated Dose | COMPLETED | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 2 | |
| Phase I - Maximum Tolerated Dose | COMPLETED | Phase IIA Arm 2 | 0 | |
| Phase I - Maximum Tolerated Dose | COMPLETED | Phase IIB Arm 2 | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events160
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 | Abdominal pain | Gastrointestinal disorders | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 5 | 8 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 2 | 2 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 2 | 8 | 4 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 0 | 2 | 0 |
| other | Alanine aminotransferase increased | Investigations | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 3 | 8 | 5 |
| other | Alanine aminotransferase increased | Investigations | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 0 | 2 | 0 |
| other | Alkaline phosphatase increased | Investigations | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 1 | 8 | 1 |
| other | Alkaline phosphatase increased | Investigations | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 0 | 2 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 3 | 8 | 4 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 0 | 2 | 0 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 7 | 8 |
| Total, all-cause mortality | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 2 | 2 |
| Total, other adverse events | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 8 | 8 |
| Total, other adverse events | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 2 | 2 |
| Total, serious adverse events | Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg | 3 | 8 |
| Total, serious adverse events | Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg | 2 | 2 |
Source ClinicalTrials.gov
Papers0
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg vs Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg: Phase I Number of Participants With a Dose Limiting Toxicity (DLT) | Trial comparisons |
Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg vs Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg vs Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg: deaths from any cause | Trial comparisons |
| Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg vs Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
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