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Non-small Cell Lung Cancer(NSCLC)Phase 1/2NCT01712217

A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib

A Phase 1/2 study testing AT13387 and Crizotinib in people with Non-small Cell Lung Cancer(NSCLC), run by Astex Pharmaceuticals, Inc. at 65 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer(NSCLC)
What is being tested?
AT13387 and Crizotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
65 sitesin 5 countries
Study dates
Oct 2012to 16 May 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women 18 years of age or older
  • Must have Non-small Cell Lung Cancer with ALK+ mutation or other mutations or rearrangements potentially sensitive to crizotinib
  • Measurable disease
  • Must have been receiving or have received crizotinib
  • Have adequate cardiac, bone marrow, liver and kidney function
  • Must be willing and able to provide written informed consent and comply with the protocol and study procedures

Who cannot join

  • Prior anti-cancer treatment with any HSP90 inhibitor
  • Have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug
  • 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
  • Abnormal heart function
  • Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
  • Hypersensitivity of AT13387 or other components of the drug product
Show all 9Show fewer
  • Treatment with an investigational drug within 3 weeks prior to the first dose of study drug
  • Severe systemic diseases or active uncontrolled infections
  • Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus

Trial locations and contacts

65 sites in 5 countries.

65 sites in 5 countries

United States38 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Northwestern University The Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Oncology Hematology in Cincinnati

    Cincinnati, Ohio, 45242

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • The West Clinic

    Germantown, Tennessee, 38138

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27409

  • The Pennsylvania State University-Penn State

    Hershey, Pennsylvania, 17033-0850

  • Indiana University Melvin and and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of California, San Diego Medical Center

    La Jolla, California, 92093-0698

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA Medical Center

    Los Angeles, California, 90095

  • University of Wisconsin-Carbone Cancer Center

    Madison, Wisconsin, 53579

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale University School of Medicine-Yale Cancer Center

    New Haven, Connecticut, 06519

  • Columbia University Medical Center

    New York, New York, 10032

  • Christiana Hospital

    Newark, Delaware, 19713

  • University of Nebraska Medical Center Eppley Cancer Center

    Omaha, Nebraska, 68198

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Mayo Clinic-Rochester

    Rochester, Minnesota, 55905

  • Sharp Clinical Oncology Research-Sharp Memorial Hospital

    San Diego, California, 92123

  • Mayo Clinic-Scottsdale

    Scottsdale, Arizona, 85259

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • University of Washington Medical Center

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612-9497

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

France10 sites

  • Centre Hospitalier Regional Universitaire Besancon

    Besançon, 25030

  • CHU de Caen-Hopital Cote de Nacre

    Caen, 14033

  • Hopital Saint Antoine

    Créteil, 94010

  • Centre Hospitalier de Grenoble

    Grenoble, 38043

  • CHRU de Lille

    Lille, 59037

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Hopital Tenon

    Paris, 75020

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Toulouse-Hopital Larrey

    Toulouse, 31 059

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

South Korea8 sites

  • Chungbuk National University Hospital

    Cheongju-si, 362-711

  • The Catholic University of Korea, St. Vincent's Hospital

    Gyeonggi-do, 442-723

  • Chonnam National University Hwasun Hospital

    Hwasun-gun Jeonnam, 519-809

  • National Cancer Center

    Korea, 410-769

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Canada5 sites

  • Atlantic Clinical Cancer Research Unit

    Halifax, Nova Scotia, B3H 1V7

  • McGill University Health Center

    Montreal, Quebec, H3A 1A1

  • Institut Universitaire de Cardiologie et de Pneumologie De Quebec

    Sainte-Foy, Quebec, G1V 4G5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Cancer Care Manitoba

    Winnipeg, R3E OV9

Other trials in Canada

Spain4 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitari Quiron Dexeus Barcelona

    Barcelona, 08028

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

Other trials in Spain

About this study

Official title: A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)

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.

Read the 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.

Being tested
AT13387, Crizotinib
Keywords
Non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AT13387Drug

    HSP90 inhibitor

  • CrizotinibDrug

    Also called Xalkori

    ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene1, receptor tyrosine kinase) inhibitor

Study groups in NCT01712217
Study groupRoleWhat they receive
AT13387 and CrizotinibExperimentalPart 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.
Receives: Drug: AT13387; Drug: Crizotinib
Crizotinib versus crizotinib + AT13387Active comparatorPart 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.
Receives: Drug: AT13387; Drug: Crizotinib
AT13387 or AT13387 + crizotinibActive comparatorPart 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.
Receives: Drug: AT13387; Drug: Crizotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: The incidence of dose limiting toxicities when AT13387 is administered in combination with crizotinib.

    • Number of patients with adverse events

    Measured: 12 months

  2. Part B: The comparison of objective response rate by RECIST 1.1 between crizotinib alone and the combination of crizotinib + AT13387.

    • Change in tumor measurements by RECIST 1.1 every 8 weeks

    Measured: 18 months

  3. 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.

    • Change in tumor measurements by RECIST 1.1 every 8 weeks

    Measured: 18 months

Secondary outcomes (4)

  1. Part A: Pharmacokinetics of combination treatment with AT13387 and crizotinib

    • Area under the plasma concentration versus time curve (AUC) of AT13387 and crizotinib alone and in combination Week 4
    • Maximum concentration (Cmax) OF AT13387 and crizotinib alone and in combination by Week 4

    Measured: 12 months

  2. Part A: Assess antitumor activity of crizotinib + AT13387 combination, circulating tumor cells (CTCs) response, progression free survival (PFS) and overall survival (OS).

    • Change in tumor measurements by RECIST 1.1 every 8 weeks
    • Change in CTCs from baseline every 4 weeks
    • Assessment of PFS and OS as measured by weeks

    Measured: 12 months

  3. 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

    • Number of patients with adverse events
    • PFS and OS as measured in weeks
    • Response rate as measured by RECIST 1.1 every 8 weeks

    Measured: 18 months

  4. 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

    • Number of patients with adverse events
    • PFS and OS as measured in weeks

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2016
  4. Study completion16 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01712217
Sponsor's protocol ID
AT13387-05
Other IDs
2012-001575-37
Status last verified
Aug 2024
First submitted
11 Oct 2012
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AT13387 and Crizotinib in people with Non-small Cell Lung Cancer(NSCLC), run by Astex Pharmaceuticals, Inc. at 65 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, France, South Korea, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: The incidence of dose limiting toxicities when AT13387 is administered in combination with crizotinib. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01712217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

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