--- title: A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib nct_id: NCT01712217 overall_status: COMPLETED phase: PHASE1, PHASE2 sponsor: Astex Pharmaceuticals, Inc. study_type: INTERVENTIONAL primary_condition: Non-small Cell Lung Cancer(NSCLC) countries: United States, Canada, France, South Korea, Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01712217.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01712217" ct_last_update_post_date: 2024-08-02 last_seen_at: "2026-05-12T06:02:19.985Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib **Official Title:** A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC) **NCT ID:** [NCT01712217](https://clinicaltrials.gov/study/NCT01712217) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE1, PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 220 - **Lead Sponsor:** Astex Pharmaceuticals, Inc. - **Conditions:** Non-small Cell Lung Cancer(NSCLC) - **Start Date:** 2012-10 - **Completion Date:** 2017-05-16 - **CT.gov Last Update:** 2024-08-02 ## Brief Summary The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer. ## Detailed Description This is a 3-part phase 1-2 study in patients with anaplastic lymphoma kinase (ALK) + or other potentially crizotinib-sensitive NSCLC who have been receiving crizotinib. Part A is a single-arm, Phase 1, open-label, dose escalation design in patients with NSCLC who have already been receiving crizotinib for at least 8 weeks and continue to tolerate therapy. Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the maximum tolerated dose established in Part A. Part C is an open-label, randomized, Phase 2, Simon's 2 stage design evaluating single agent AT13387 or combination AT13387 + crizotinib at the MTD established in Part A in patients who progressed on crizotinib at any time. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Men or women 18 years of age or older 2. Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib 3. Measurable disease 4. Must have been receiving or have received crizotinib 5. Have adequate cardiac, bone marrow, liver and kidney function 6. Must be willing and able to provide written informed consent and comply with the protocol and study procedures Exclusion Criteria: 1. Prior anti-cancer treatment with any HSP90 inhibitor 2. Have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug 3. Prior malignancy other than adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, low-grade cervical cancer, non-metastatic prostate cancer, or have been disease-free for at least 3 years 4. Abnormal heart function 5. Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors 6. Hypersensitivity of AT13387 or other components of the drug product 7. Treatment with an investigational drug within 3 weeks prior to the first dose of study drug 8. Severe systemic diseases or active uncontrolled infections 9. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus ``` ## Arms - **AT13387 and Crizotinib** (EXPERIMENTAL) — Part A is a single-arm, Phase 1, open-label, dose-escalation design in patients with NSCLC who have already been receiving crizotinib 250 mg by mouth (PO) twice daily (BID) for at least 8 weeks and are still tolerating treatment at that dose. Patients will continue treatment with crizotinib + escalating doses of AT13387 IV weekly for 3 weeks in a 4-week cycle. Each cohort will consist of at least 6 patients until the maximum tolerated dose (MTD) is reached. An additional 12 patients will be treated at the MTD level of AT13387 in combination with crizotinib to confirm the safety profile of the combination at that dose level. - **Crizotinib versus crizotinib + AT13387** (ACTIVE_COMPARATOR) — Part B is a Phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + AT13387 at the MTD established in Part A. Part B will enroll 128 patients with NSCLC who have been treated with crizotinib for at least 8 weeks and are still tolerating treatment without evidence of disease progression. - **AT13387 or AT13387 + crizotinib** (ACTIVE_COMPARATOR) — Part C is an open-label, randomized, Phase 2, Simon's 2-stage design of AT13387 administered alone once weekly for 3 weeks (QW×3) or in combination with crizotinib at the MTD established in Part A. ## Interventions - **AT13387** (DRUG) — HSP90 inhibitor - **Crizotinib** (DRUG) — ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene1, receptor tyrosine kinase) inhibitor ## Primary Outcomes - **Part A: The incidence of dose limiting toxicities when AT13387 is administered in combination with crizotinib.** _(time frame: 12 months)_ — \- Number of patients with adverse events - **Part B: The comparison of objective response rate by RECIST 1.1 between crizotinib alone and the combination of crizotinib + AT13387.** _(time frame: 18 months)_ — \- Change in tumor measurements by RECIST 1.1 every 8 weeks - **Part C: The objective overall response rate for AT13387 alone and the objective response rate (CR+PR) for AT13387 + crizotinib at Stage 1 and Stage 2 of the Simon's 2-stage design.** _(time frame: 18 months)_ — \- Change in tumor measurements by RECIST 1.1 every 8 weeks ## Secondary Outcomes - **Part A: Pharmacokinetics of combination treatment with AT13387 and crizotinib** _(time frame: 12 months)_ - **Part A: Assess antitumor activity of crizotinib + AT13387 combination, circulating tumor cells (CTCs) response, progression free survival (PFS) and overall survival (OS).** _(time frame: 12 months)_ - **Part B: Assess safety of AT13387 in combination with crizotinib; compare PFS and OS between crizotinib and crizotinib + AT13387; and assess overall response rate (CR + PR) in crizotinib patients who crossover to crizotinib + AT13387** _(time frame: 18 months)_ - **Part C: Assess safety of AT13387 alone and in combination with crizotinib who progressed on crizotinib treatment; and compare the PFS and OS of AT13387 administered alone or in combination with crizotinib** _(time frame: 18 months)_ ## Locations (65) - Mayo Clinic-Scottsdale, Scottsdale, Arizona, United States - University of California, San Diego Medical Center, La Jolla, California, United States - USC Norris Comprehensive Cancer Center, Los Angeles, California, United States - UCLA Medical Center, Los Angeles, California, United States - Sharp Clinical Oncology Research-Sharp Memorial Hospital, San Diego, California, United States - Innovative Clinical Research Institute, Whittier, California, United States - University of Colorado Denver, Aurora, Colorado, United States - Yale University School of Medicine-Yale Cancer Center, New Haven, Connecticut, United States - Christiana Hospital, Newark, Delaware, United States - Florida Hospital Cancer Institute, Orlando, Florida, United States - H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States - Northwestern University The Feinberg School of Medicine, Chicago, Illinois, United States - University of Chicago, Chicago, Illinois, United States - Indiana University Melvin and and Bren Simon Cancer Center, Indianapolis, Indiana, United States - University of Michigan Medical Center, Ann Arbor, Michigan, United States - Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States - Mayo Clinic-Rochester, Rochester, Minnesota, United States - Washington University School of Medicine, St Louis, Missouri, United States - University of Nebraska Medical Center Eppley Cancer Center, Omaha, Nebraska, United States - Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States - Columbia University Medical Center, New York, New York, United States - Montefiore Medical Center, The Bronx, New York, United States - Duke University Medical Center, Durham, North Carolina, United States - Cone Health Cancer Center, Greensboro, North Carolina, United States - Oncology Hematology in Cincinnati, Cincinnati, Ohio, United States - University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States - Cleveland Clinic, Cleveland, Ohio, United States - Ohio State University Medical Center, Columbus, Ohio, United States - Providence Portland Medical Center, Portland, Oregon, United States - The Pennsylvania State University-Penn State, Hershey, Pennsylvania, United States - Thomas Jefferson University, Philadelphia, Pennsylvania, United States - The West Clinic, Germantown, Tennessee, United States - Sarah Cannon Research Institute, Nashville, Tennessee, United States - University of Texas Southwestern Medical Center, Dallas, Texas, United States - Virginia Cancer Specialists, Fairfax, Virginia, United States - Swedish Cancer Institute, Seattle, Washington, United States - University of Washington Medical Center, Seattle, Washington, United States - University of Wisconsin-Carbone Cancer Center, Madison, Wisconsin, United States - Atlantic Clinical Cancer Research Unit, Halifax, Nova Scotia, Canada - McGill University Health Center, Montreal, Quebec, Canada - Institut Universitaire de Cardiologie et de Pneumologie De Quebec, Sainte-Foy, Quebec, Canada - Princess Margaret Hospital, Toronto, Ontario, Canada - Cancer Care Manitoba, Winnipeg, Canada - Centre Hospitalier Regional Universitaire Besancon, Besançon, France - CHU de Caen-Hopital Cote de Nacre, Caen, France - Hopital Saint Antoine, Créteil, France - Centre Hospitalier de Grenoble, Grenoble, France - CHRU de Lille, Lille, France - Institut Paoli-Calmettes, Marseille, France - Hopital Tenon, Paris, France - Centre Hospitalier Lyon Sud, Pierre-Bénite, France - CHU Toulouse-Hopital Larrey, Toulouse, France - Institut Gustave Roussy, Villejuif, France - Chungbuk National University Hospital, Cheongju-si, South Korea - The Catholic University of Korea, St. Vincent's Hospital, Gyeonggi-do, South Korea - Chonnam National University Hwasun Hospital, Hwasun-gun Jeonnam, South Korea - National Cancer Center, Korea, South Korea - Seoul National University Bundang Hospital, Seongnam, South Korea - Severance Hospital, Yonsei University Health System, Seoul, South Korea - Samsung Medical Center, Seoul, South Korea - Asan Medical Center, Seoul, South Korea - Hospital Germans Trias i Pujol, Badalona, Spain - Hospital Universitari Quiron Dexeus Barcelona, Barcelona, Spain - Centro Integral Oncologico Clara Campal, Madrid, Spain - Hospital Regional Universitario de Malaga, Málaga, Spain ## Recent Field Changes (last 30 days) - `locations.university of colorado denver|aurora|colorado|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `locations.yale university school of medicine-yale cancer center|new haven|connecticut|united states` — added _(2026-05-12)_ - `locations.christiana hospital|newark|delaware|united states` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.mayo clinic-scottsdale|scottsdale|arizona|united states` — added _(2026-05-12)_ - `locations.university of california, san diego medical center|la jolla|california|united states` — added _(2026-05-12)_ - `locations.usc norris comprehensive cancer center|los angeles|california|united states` — added _(2026-05-12)_ - `locations.ucla medical center|los angeles|california|united states` — added _(2026-05-12)_ - `locations.sharp clinical oncology research-sharp memorial hospital|san diego|california|united states` — added _(2026-05-12)_ - `locations.innovative clinical research institute|whittier|california|united states` — added _(2026-05-12)_ - `locations.florida hospital cancer institute|orlando|florida|united states` — added _(2026-05-12)_ - `locations.h. lee moffitt cancer center & research institute|tampa|florida|united states` — added _(2026-05-12)_ - `locations.northwestern university the feinberg school of medicine|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.university of chicago|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.indiana university melvin and and bren simon cancer center|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.university of michigan medical center|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.barbara ann karmanos cancer institute|detroit|michigan|united states` — added _(2026-05-12)_ - `locations.mayo clinic-rochester|rochester|minnesota|united states` — added _(2026-05-12)_ - `locations.washington university school of medicine|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.university of nebraska medical center eppley cancer center|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.dartmouth hitchcock medical center|lebanon|new hampshire|united states` — added _(2026-05-12)_ - `locations.columbia university medical center|new york|new york|united states` — added _(2026-05-12)_ - `locations.montefiore medical center|the bronx|new york|united states` — added _(2026-05-12)_ - `locations.duke university medical center|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.cone health cancer center|greensboro|north carolina|united states` — added _(2026-05-12)_ - `locations.oncology hematology in cincinnati|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.university of cincinnati cancer institute|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.cleveland clinic|cleveland|ohio|united states` — added _(2026-05-12)_ - `locations.ohio state university medical center|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.providence portland medical center|portland|oregon|united states` — added _(2026-05-12)_ - `locations.the pennsylvania state university-penn state|hershey|pennsylvania|united states` — added _(2026-05-12)_ - `locations.thomas jefferson university|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.the west clinic|germantown|tennessee|united states` — added _(2026-05-12)_ - `locations.sarah cannon research institute|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.university of texas southwestern medical center|dallas|texas|united states` — added _(2026-05-12)_ - `locations.virginia cancer specialists|fairfax|virginia|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01712217.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01712217* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*