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Topoisomerase I inhibitor

PLX038 + Rucaparib for Solid Cancers and Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Anish Thomas, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with histologically confirmed solid tumors (Phase I), OR histologically or cytologically confirmed SCLC (Phase II), OR histologically or cytologically confirmed extra-pulmonary small cell carcinomas (Phase II)

ECOG performance status less than or equal to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up disease progression at 4 months

Awards & highlights

Study Summary

This trial is testing a combination of two drugs to see if it can safely shrink tumors in people with solid tumors, SCLC, or small cell cancer outside their lungs.

Who is the study for?

Adults with solid tumors or small cell cancers, including lung and extra-pulmonary, who've progressed after standard chemotherapy. They must be able to perform daily activities to a certain extent, have adequate organ function, agree to use contraception during the study and for 6 months after, and sign informed consent. Excluded are those with severe genetic enzyme deficiencies, active viral infections on antivirals, recent radiotherapy or other treatments, breastfeeding women, and those with uncontrolled illnesses.Check my eligibility

What is being tested?

The trial is testing PLX038 (a new form of chemo) combined with rucaparib (a PARP inhibitor) in shrinking tumors. Participants will receive PLX038 intravenously on day one of each cycle (21 days), followed by oral rucaparib from day three to nineteen. The goal is finding a safe dosage that effectively reduces tumor size.See study design

What are the potential side effects?

Potential side effects include typical reactions associated with chemotherapy such as nausea, fatigue, hair loss; plus specific risks related to PARP inhibitors like anemia and increased infection risk due to lowered blood counts. Organ inflammation could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed diagnosis of a solid tumor, small cell lung cancer, or small cell cancer outside the lungs.

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I can take care of myself and perform daily activities.

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My liver is functioning within the required levels for the trial.

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My kidney function is within the required range.

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I have brain metastases but no symptoms, or they have been treated.

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My cancer has worsened after initial chemotherapy and I have no other treatment options.

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I am 18 years old or older.

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My condition cannot be cured with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease progression at 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~disease progression at 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease progression at 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Maximum Tolerated Dose (MTD) of PLX038 (PEGylated SN38) in Combination With Rucaparib

Phase II: Clinical Benefit Rate

Secondary outcome measures

Phase I - Number of Participants Who Experience a Clinical Response (Complete Response (CR)+Partial Response (PR)

Phase I and Phase II Grades 1-5 Serious and/or Non-serious Adverse Events Related to PLX038 (PEGylated SN38) and/or Rucaparib

Phase IIA Overall Survival

+1 more

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Phase I Number of Participants With a Dose Limiting Toxicity (DLT)

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase IIB Arm 2Experimental Treatment3 Interventions

Phase IIB Participants with extra-pulmonary small cell carcinomas enrolled at the maximum tolerated dose (MTD) of PLX038 (PEGylated SN38) and rucaparib after the MTD of PLX038 and rucaparib is established. Level 2, PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 3-19 twice a day (BID), total dose, 600 mg by mouth (PO); Level 3, PLX038, every 3 weeks, 1.7 g/m^2, intravenous (IV); Rucaparib, days 3-19 twice a day (BID), total dose, 600 mg by mouth (PO); Level 4, PLX038, every 3 weeks, 2.3 g/m^2, intravenous (IV); Rucaparib, days 3-19 twice a day (BID), total dose, 600 mg by mouth (PO); Level 2A PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 5-19 twice a day (BID), total dose, 400 mg by mouth (PO); and/or Level 3A. PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 5-19 twice a day (BID), total dose, 600 mg by mouth (PO).

Group II: Phase IIA Arm 2Experimental Treatment3 Interventions

Phase IIA Participants with small cell lung cancer (SCLC) enrolled at the maximum tolerated dose (MTD) of PLX038 (PEGylated SN38) and rucaparib after the MTD of PLX038 and rucaparib is established. Level 2, PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 3-19 twice a day (BID), total dose, 600 mg by mouth (PO); Level 3, PLX038, every 3 weeks, 1.7 g/m^2, intravenous (IV); Rucaparib, days 3-19 twice a day (BID), total dose, 600 mg by mouth (PO); Level 4, PLX038, every 3 weeks, 2.3 g/m^2, intravenous (IV); Rucaparib, days 3-19 twice a day (BID), total dose, 600 mg by mouth (PO); Level 2A PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 5-19 twice a day (BID), total dose, 400 mg by mouth (PO); and/or Level 3A. PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 5-19 twice a day (BID), total dose, 600 mg by mouth (PO).

Group III: Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mgExperimental Treatment3 Interventions

Phase I - Participants with solid tumors enrolled to PLX038 (PEGylated SN38) and rucaparib escalation dose levels. PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 3-19 twice a day (BID), total dose, 400 mg by mouth (PO)

Group IV: Phase I Arm 1 Level -1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 200 mgExperimental Treatment3 Interventions

Phase I - Participants with solid tumors enrolled to PLX038 (PEGylated SN38) and rucaparib escalation dose levels. PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 5-19 twice a day (BID), total dose, 200 mg by mouth (PO)

Group V: Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mgExperimental Treatment3 Interventions

Phase I Participants with solid tumors enrolled to PLX038 (PEGylated SN38) and rucaparib escalation dose levels. PLX038, every 3 weeks, 1.3 g/m^2, intravenous (IV); Rucaparib, days 5-19 twice a day (BID), total dose, 300 mg by mouth (PO)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PLX038

2016

Completed Phase 1

~40

Ondansetron

2011

Completed Phase 4

~4010

Rucaparib

2016

Completed Phase 3

~1990

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,143 Total Patients Enrolled

Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)

9 Previous Clinical Trials

802 Total Patients Enrolled

Media Library

PLX038 (Topoisomerase I inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04209595 — Phase 1 & 2

Small Cell Lung Cancer Research Study Groups: Phase IIA Arm 2, Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg, Phase IIB Arm 2, Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg, Phase I Arm 1 Level -1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 200 mg

Small Cell Lung Cancer Clinical Trial 2023: PLX038 Highlights & Side Effects. Trial Name: NCT04209595 — Phase 1 & 2

PLX038 (Topoisomerase I inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209595 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To the best of your knowledge, are there any other similar ongoing studies?

"PLX038 has been under clinical study since 2014. The first trial, sponsored by Clovis Oncology, Inc., was completed that year with 564 participants. Based on the success of the initial Phase 3 drug trial, PLX038 received approval and is now being studied in 35 active trials involving 861 cities and 34 countries."

Answered by AI

How many test subjects are included in this experiment?

"That is correct. The information available on clinicaltrials.gov indicates that this study is still recruiting patients. This trial was first posted on April 8th, 2020 and was last edited on November 16th, 2020. So far, 65 patients have been admitted at 1 site."

Answered by AI

Are we still enrolling people for this experiment?

"Yes, as per the clinicaltrials.gov website, this study is still looking for willing participants. The trial was initially posted on April 8th 2020 with the latest update being from November 16th 2022."

Answered by AI

What goals does this clinical trial hope to accomplish?

"The primary metric that will be used to determine success in this clinical trial is MTD during Phase I, with secondary measures including Toxicities, Overall Survival, and Clinical Response Rate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers

Anish Thomas 2020. "PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04209595.

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