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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

Must not have

Participants with known Gilbert s syndrome

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that may impair the participants tolerance of study treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up disease progression at 4 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Gilbert's syndrome.

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I do not have any severe illnesses or social situations that could affect my treatment.

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I haven't had cancer treatment or major surgery in the last 2 weeks.

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I am not on antiviral drugs for HIV, HCV, or HBV.

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I am not pregnant or breastfeeding.

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I have a specific genetic variant that affects my drug processing.

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I have had allergic reactions to drugs similar to PLX038 or rucaparib.

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I am not taking strong medication that affects liver enzymes during the trial.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Phase II: Clinical Benefit Rate

Secondary study objectives

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 study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2007

Completed Phase 4

~3690