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Protocol Details

Phase I/II Trial of PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


PARP Inhibitor;
DDR Inhibitor

Recruitment Keyword(s)



Small Cell Lung Cancer;
Extra-Pulmonary Small Cell Carcinomas

Investigational Drug(s)

PLX038 (PEGylated SN38)

Investigational Device(s)



Drug: PLX038
Drug: Rucaparib
Drug: Ondansetron

Supporting Site

National Cancer Institute


Drugs known as poly-adenosine diphosphate ribose polymerase (PARP) inhibitors are known to help stop tumor growth in patients with breast, ovarian cancers and many other cancers including prostate and pancreatic cancers. Many research studies done in animals and human cells have shown that these types of drugs can improve how well chemotherapy works. Standard chemotherapy can be too toxic to be combined with PARP inhibitors. In this study, we use a new form of chemotherapy called PLX038 (PEGylated SN38) to see if it can be safely combined with PARP inhibitors to shrink tumors.


To find a safe combination of PLX038 and rucaparib, and to see if this mix will cause tumors to shrink.


People age 18 and older with solid tumors, small cell lung cancer (SCLC), or small cell cancer outside their lungs.


Participants will be screened with:

Physical exam

Blood tests

Records of their diagnosis (or they will have a tumor biopsy).

A review of their symptoms and medications.

A review of their ability to perform their normal activities.

Electrocardiograms, to measure the electrical activity of the heart.

Computed tomography (CT) scans of the chest, abdomen, and pelvis. CT scans are a series of X-rays.

Participants will get PLX038 by intravenous catheter on Day 1 of each cycle (1 cycle = 21 days). For this, a small plastic tube is put into an arm vein. They will take rucaparib twice daily by mouth on Days 3 to 19 of each cycle. They will keep a medicine diary.

Participants may give a hair sample. They may have optional tumor biopsies.

Screening tests are repeated throughout the study.

About 30 days after treatment ends, participants will have a safety follow-up visit. They will give blood samples, talk about their health, and get a physical exam. Then they will be called or emailed every 6 months.

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-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).

-Age >=18 years. Because no dosing or adverse event data are currently available on the use of PLX038 in combination with rucaparib in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.

-Subjects must have progressed on or after standard first-line systemic chemotherapy and have no effective treatment options.

-Participants must have disease that is not amenable to potentially curative resection.

-Participants must have measurable disease per RECIST 1.1.

-Participants with asymptomatic brain metastases and treated brain metastases are eligible.

-ECOG performance status <=2.

-Adequate hematological function defined by:

--white blood cell (WBC) count >=3 x 10^9/L,

--absolute neutrophil count (ANC) >=1.5 x10^9/L,

--platelet count >=100 x 10^9/L,

--Hgb >=9 g/ dL

-Adequate hepatic function defined by:

--a total bilirubin level <=1.5 x ULN,

--an AST level<=2.5 x ULN, (<=5X ULN if liver metastasis)

--an ALT level <=2.5 x ULN, (<=5X ULN if liver metastasis).

-Adequate renal function defined by:

--Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl): < 1.5x institution upper limit of normal OR >=45 mL/min/1.73 m^2 for participant with creatinine levels >=1.5 X institutional ULN.

Note: Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.

-The effects of the study treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment and up to 6 months after the last dose of the study drug (s). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

-Subjects must be able to understand and willing to sign a written informed consent document.


-Participants who are receiving any other investigational agents.

-Systemic anti-cancer treatment or major surgery within 2 weeks prior to enrollment.

-Radiotherapy within 24 hours prior to enrollment.

-Participants who require treatment with strong inhibitors or inducers of CYP3A or with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038.

-Participants with known Gilbert s syndrome.

-Participants homozygous for the UGT1A1*28 variant allele with severely reduced UGT1A1 activity.

-Participants with HIV, HCV, HBV status on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and/or pharmacodynamic interactions.

-History of allergic reactions attributed to compounds of similar chemical or biologic composition to PLX038 or rucaparib.

-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.

-Pregnant women are excluded from this study because PEGSN38 and rucaparib potential for teratogenic or abortifacient effects are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with PEGSN38 and rucaparib, breastfeeding should be discontinued if the mother is treated with study drugs.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Anish Thomas, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5330
(240) 760-7343

Danielle F. Pinkiert, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 12C101
10 Center Drive
Bethesda, Maryland 20892
(240) 858-7566

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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