Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers

Study summary

About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard dose of crizotinib. If this dose does not cause significant side effects, it will be increased as new patients take part in the study. The study will only be open at Memorial Sloan Kettering Cancer Center.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGanetespib (STA-9090) and crizotinib

The study team can explain what participation involves.

Who it may be forALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 30, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
Interventions being studied: Drug: Ganetespib (STA-9090) and crizotinib

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How this study is categorized

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

Biomarkers

ALK→

Treatment approach

Targeted therapy→

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

Histologically or cytologically proven diagnosis confirmed at MSKCC of advanced lung adenocarcinoma that is locally advanced or metastatic (stage III/IV).
Positive for translocation or inversion events involving the ALK gene locus as determined standard methods (including but not limited to by FISH and IHC testing).
No prior treatment with crizotinib, but they may have received prior cytotoxic chemotherapy.
Age ≥ 18 years.
Measurable (RECIST 1.1) indicator lesion not previously irradiated.
Karnofsky Performance Status ≥ 70%
Able to take oral medications
A negative serum pregnancy test obtained within two weeks prior to administration of the experimental agents in all pre-menopausal women (last menstrual period ≤ 24 months ago).
All women of child bearing potential (WOCBP) and sexually active men must agree to use adequate methods of birth control throughout the study which include use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy and/or tubal libation and total abstinence.

Reasons someone may not be able to joinExclusion criteria

Prior crizotinib therapy
Inadequate recovery from any toxicity related to prior treatment (to Grade 1 or baseline).
Inadequate hematologic function defined as:
Absolute neutrophil count (ANC) \< 1,000 cells/mm³.
Platelet count \< 75,000/mm³
Hemoglobin \< 9.0g/dL. Inadequate hepatic function defined by:
AST and/or ALT \> 3x upper limited of normal (ULN).
Total bilirubin \> 2x ULN.
Alkaline phosphatase \> 3x ULN.
Patients with hepatic metastases may have ALT/AST ≤ 5x ULN.
Patients with hepatic and/or bone metastases may have an AP ≤ 5x ULN.
Inadequate renal function defined by serum creatinine \> 2x ULN Uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs/symptoms related to infection without improvement, despite appropriate anti-infective medications or other treatment).
Patients with clinically active brain metastasis (requiring therapy with steroids or radiation therapy). Patients with clinically stable brain metastases (previously treated or untreated) for two weeks are eligible.
Significant cardiac disease (e.g. New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias).
Previously or current malignancies at other sites within the last 2 years, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, or prostate cancer that does not require active treatment per National Comprehensive Cancer Network (NCCN) guidelines.
Women who are pregnant or lactating
Use of drugs or food that are known potent CYP3A4 inhibitors (see Appendix C)
Use of drugs that are known potent CYP3A4 inducers (see Appendix D)
Any other condition that, in the opinion of the Investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study.

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

Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ SuffolkCommack, New York
Memorial Sloan Kettering Cancer CenterNew York, New York
Memorial Sloan Kettering at Mercy Medical CenterRockville Centre, New York
Memoral Sloan Kettering Cancer Center at PhelpsSleepy Hollow, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 30, 2020. Always confirm current availability with the study team.

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