TerminatedPhase 1 / Phase 2NCT03366103
Official study title

Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors

Study summary

This phase I/II trial studies the best dose and side effects of navitoclax and how well it works when given together with vistusertib in treating patients with small cell lung cancer and solid tumors that have come back (relapsed). Drugs used in chemotherapy, such as navitoclax, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vistusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving navitoclax and vistusertib may work better than navitoclax alone in treating patients with small cell lung cancer and solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNavitoclax and Vistusertib

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 17, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
National Cancer Institute (NCI)
Interventions being studied
Biological: Navitoclax; Drug: Vistusertib
02
Explore related studies

How this study is categorized

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

03
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
  • PHASE 1 SPECIFIC ELIGIBILITY CRITERIA
  • Patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  • PHASE 2 SPECIFIC ELIGIBILITY CRITERIA
  • Patients must have histologically or cytologically confirmed small cell lung cancer whose disease has relapsed or progressed after \>= 1 prior therapy, one of which must have been a platinum doublet; pathology confirmation must be done at Sidney Kimmel Comprehensive Cancer Center (SKCCC) or at the local participating site
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) by chest x-ray or as \>= 10 mm (\>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
  • Subjects must be willing to undergo 2 sets of core needle biopsies (pre-treatment and on-treatment), if there are lesions amenable to biopsy; an optional core biopsy will be requested at progression
  • GENERAL ELIGIBILITY CRITERIA
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
  • Life expectancy of greater than 12 weeks
  • Leukocytes \>= 3,000/mcL
  • Absolute neutrophil count \>= 1,500/mcL
  • Hemoglobin \>= 9.0 g/dL
  • Platelets \>= 100,000/mcL
  • Activated partial thromboplastin time (aPTT), prothrombin time (PT) =\< 1.2 x upper limit of normal (ULN)
  • Total bilirubin =\< 1.5 x ULN (patients with Gilbert's syndrome may have serum bilirubin \> 1.5 ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN if no demonstrable liver metastases or =\< 5 x ULN in the presence of liver metastases
  • Creatinine =\< 1.5 x ULN and concurrent creatinine clearance (CrCl) \>= 50 mL/min/1.73 m\^2 for patients with creatinine (Cr) \> 1.5 x ULN
  • Proteinuria \< 1+ on dipstick testing (if 2+ seen on first test, retest \>= 24 hours later)
  • Patients with a history of central nervous system (CNS) metastases must have documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids
  • Patients must have completed chemotherapy, biological or radiotherapy \>= 3 weeks prior to entering the study
  • Patients must have recovered to =\< grade 1 adverse events or to =\< grade 2 alopecia and sensory neuropathy due to prior treatment
  • Patients must be able to understand and the willingness to sign a written informed consent document
  • Patients must be able to swallow pills
  • The effects of navitoclax and vistusertib on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days following completion of therapy; for women this should include one highly effective method of contraception and one barrier method as defined below
  • Highly effective methods include:
  • Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration);
  • Vasectomized partner;
  • Medroxyprogesterone acetate depot injection;
  • Placement of a copper-banded intrauterine device (IUD) or intrauterine system (IUS);
  • Bilateral tubal ligation;
  • Barrier methods include:
  • Condom;
  • Occlusive cap (e.g. diaphragm or cervical/vault caps) with spermicide
  • Please note: use of other oral, injected or implanted hormonal methods of contraception cannot be considered highly effective as it is currently unknown whether vistusertib may reduce their effectiveness; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
  • Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completion of therapy
  • Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment, women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post-menopausal (amenorrheic for at least 12 months)
  • 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; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 90 days after completion of navitoclax and/or vistusertib administration
Reasons someone may not be able to joinExclusion criteria

PHASE 2 SPECIFIC

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

04
Study sites

U.S. locations

  • Los Angeles County-USC Medical CenterLos Angeles, California
  • USC / Norris Comprehensive Cancer CenterLos Angeles, California
  • Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, Maryland
  • Massachusetts General Hospital Cancer CenterBoston, Massachusetts
  • Brigham and Women's HospitalBoston, Massachusetts
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • Memorial Sloan Kettering Basking RidgeBasking Ridge, New Jersey
  • Memorial Sloan Kettering MonmouthMiddletown, New Jersey
  • Memorial Sloan Kettering BergenMontvale, New Jersey
  • Memorial Sloan Kettering CommackCommack, New York
  • Memorial Sloan Kettering WestchesterHarrison, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 17, 2023. Always confirm current availability with the study team.

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