LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies

Study summary

This trial will investigate the combination of two anti-cancer agents to treat patients with relapsed/refractory small cell lung cancer (SCLC) and ovarian cancers. Oral topotecan has US FDA approval for treating select gynecological cancers and SCLC. LCL161 is an investigational product that has been shown in clinical trials to work together with other anti-cancer agents. In this trial, investigators will determine the optimal dose of LCL161 and topotecan to administer to patients with relapsed/refractory SCLC and ovarian cancers, and examine the safety profile of the drug combination.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLCL161 and Topotecan

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 5, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?SCRI Development Innovations, LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: SCRI Development Innovations, LLC
Interventions being studied: Drug: LCL161; Drug: Topotecan; Drug: Pegylated GCSF (PEG-GCSF)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Recurrent or relapsed→Resistant or refractory→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Dose Escalation Portion: Must have histological diagnosis of relapsed/refractory SCLC or gynecological malignancy for which topotecan would be indicated.
Dose Expansion Portion: Must have histological diagnosis of relapsed/refractory SCLC or ovarian cancer for which topotecan would be indicated.
Patients must have evidence of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer and must have previously received a platinum- / taxane-based chemotherapy regimen unless contraindicated. Only patients with platinum-resistant disease (recurrence \< 6 months after platinum-based chemotherapy) are eligible.
Patients with SCLC must have received platinum-based chemotherapy unless contraindicated.
Patients must provide written informed consent prior to any screening procedures.
Measurable or non-measurable (but evaluable) disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Eisenhauer et al. 2009)
Required baseline laboratory status:
Hemoglobin ≥90 g/L (9 g/dL)
Platelets ≥100 x 109/L (100,000/mm3)
Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/mm3)
Serum total bilirubin ≤1.5 x the upper limit of normal (ULN) (in patients with known Gilbert Syndrome, a total bilirubin ≤3.0 x ULN, with direct bilirubin ≤1.5 x ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the ULN, except for patients with tumor involvement of the liver who must have ALT and AST ≤5 x ULN
Creatinine clearance ≥ 50 mL/min, (measured by Cockcroft-Gault method):
Aged ≥18 years
Ability to swallow and retain oral medication
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Life expectancy ≥12 weeks
Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 6 months following last dose of study drug. Male patients must also refrain from donating sperm during their participation in the study.
Ability to understand the nature of this study and comply with the study procedures and laboratory tests.

Reasons someone may not be able to joinExclusion criteria

Patients with brain metastases may be enrolled if radiation and/or surgery have been completed and follow-up evaluation by computed tomography (CT) or magnetic resonance imaging (MRI) after 1 month demonstrates stable disease (SD), and the patient does not require corticosteroids or enzyme-inducing anti-epileptic medications for central nervous system disease. Patients with SCLC should have brain imaging performed within the last 2 months prior to study entry.
More than 3 prior cytotoxic chemotherapy regimens given in the metastatic setting.
Second-line ovarian cancer patients that are platinum-sensitive.
Most recent chemotherapy ≤21 days and unresolved toxicities National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03 Grade ≥2 (except alopecia)
Use of an investigational drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of LCL161. For study drugs for which 5 half-lives is ≤21 days, a minimum of 14 days between termination of the study drug and administration of LCL161 is required
Impairment of gastrointestinal function or gastrointestinal disease that may alter absorption of oral medications
Major surgery ≤3 weeks or minor surgical procedures ≤7 days prior to study entry. No waiting is required following port-a-cath placement.
Patients who are currently receiving chronic (\>14 days) treatment with corticosteroids at a dose ≥10 mg of prednisone (or its glucocorticoid equivalent) per day, or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
Patients who are currently receiving treatment with agents that are metabolized solely through cytochrome P450 (CYP) 3A4/5 (CYP3A4/5) and have a narrow therapeutic index or are strong CYP2C8 inhibitors; or are receiving treatment with agents that carry a risk for QT prolongation and are CYP3A substrates. Caution should be used in patients taking other CYP2C8- or CYP3A4/5-interacting agents.
New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities (see Appendix B), prolongation of the QTc interval to \>450 msec for males or \>470 msec for females on baseline electrocardiogram (ECG) per institutional standard or any of the following:
History or presence of ventricular tachyarrhythmia
Presence of unstable atrial fibrillation; patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Florida Cancer Specialists-SarasotaSarasota, Florida
Oklahoma University Health Science Center/Stephenson Cancer CenterOklahoma City, Oklahoma
Tennessee Oncology PLLCNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 5, 2023. Always confirm current availability with the study team.

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