A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer
NCT ID: NCT01454934
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
540 participants
INTERVENTIONAL
2011-12-09
2016-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Eribulin
Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
Arm B
TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
* Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days
* Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days
* Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days
* Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only).
Interventions
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Eribulin
Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
* Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days
* Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days
* Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days
* Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only).
Eligibility Criteria
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Inclusion Criteria
1. Histologically or cytologically confirmed diagnosis of NSCLC.
2. Documented evidence of advanced NSCLC not amenable to surgery or radiotherapy.
3. Confirmation of the presence or absence of EGFR mutations prior to study enrolment in all subjects.
4. Subjects must have received at least two prior regimens for advanced NSCLC, which should have included a platinum-based regimen and, in all subjects with tumors harbouring EGFR mutations, an EGFR TKI.
5. Radiographic evidence of disease progression on, or after, the last anti-cancer regimen prior to study entry.
6. Presence of measurable disease.
7. ECOG performance status of 0, 1, or 2.
8. Adequate bone marrow
9. Adequate renal function.
10. Adequate liver function.
11. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception.
12. Male subjects and their female partners who are of child-bearing potential must agree to use two forms of highly effective contraception.
13. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
14. Males or females aged at least 18 years (or any age greater than 18 years as determined by country legislation) at the time of informed consent.
Exclusion:
Subjects who meet any of the following criteria will be excluded from this study:
1. Subjects who have received any anti-cancer therapy within 14 days, or five half-lives of the drug (whichever is longer), prior to randomization.
2. Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to less than Grade 2.
3. Subjects who have previously been treated, or participated in a study with eribulin, whether treated with eribulin or not. The TPC option must not include the same agent which the subject received in a prior regimen.
4. Peripheral neuropathy more than CTCAE Grade 2.
5. Significant cardiovascular impairment.
6. Subjects with a high probability of Long QT Syndrome, or QTc interval \>500 ms.
7. Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy.
8. Any serious concomitant illness.
9. Known HIV positive, or have an infection requiring treatment.
10. Any malignancy that required treatment, or has shown evidence of recurrence (except for NSCLC, non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in-situ) during the 5 years prior to study entry.
11. Female subjects must not be pregnant, and must not be breastfeeding.
12. Hypersensitivity to either HalB or HalB chemical derivatives or both, or to any of the excipients of the eribulin formulation.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
Pleasant Hill, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Port Saint Lucie, Florida, United States
Decatur, Illinois, United States
Southfield, Michigan, United States
Lebanon, New Hampshire, United States
Lake Success, New York, United States
Portland, Oregon, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Herston, Queensland, Australia
Frankston, Victoria, Australia
Strasbourg, Bas Rhin, France
Marseille, Bouches-du-Rhone, France
Marseille, Bouches-duRhone, France
Bordeaux, Gironde, France
Toulouse, Haute Garonne, France
Limoges, Haute Vienne, France
Rennes, Ille Et Vilaine, France
Saint-Herblain, Loire Atlantique, France
Lille, Nord, France
Paris, Paris, France
Pierre-Bénite, Rhone, France
Villejuif, Val De Marne, France
Aschaffenburg, Bavaria, Germany
Gauting, Bavaria, Germany
Munich, Bavaria, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Recklinghausen, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Halle, Saxony-Anhalt, Germany
Hong Kong, , Hong Kong
Lido di Camaiore, Lucca, Italy
Monza, Milano, Italy
Aviano, Pordenone, Italy
Cremona, , Italy
Milan, , Italy
Siena, , Italy
Nagoya, Aichi-ken, Japan
Kashiwa-shi, Chiba, Japan
Fukuoka, Fukuoka, Japan
Hiroshima, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Kobe, Hygo-Ken, Japan
Akashi-shi, Hyōgo, Japan
Sendai, Miyagi, Japan
Nigata-shi, Nigata-Ken, Japan
Kurashiki-shi, Okayama-ken, Japan
Habinko-shi, Osaka, Japan
Osaka, Osaka, Japan
Osakasayama-shi, Osaka, Japan
Sunto-gun, Shizuoka, Japan
Chūōku, Tokyo-to, Japan
Kōtoku, Tokyo-To, Japan
Ube-shi, Yamaguchi, Japan
Kitaadachi-gun, , Japan
Gdansk, , Poland
Mrozy, , Poland
Otwock, , Poland
Sczedin, , Poland
Warsazawa, , Poland
Barnaul, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Singapore, , Singapore
Seongnam-si, Gyeonggi-do, South Korea
Suwon, Gyeonggi-do, South Korea
Seoul, Korea, South Korea
Sabadell, Barcelona, Spain
Terrassa, Barcelona, Spain
Pamplona, Navarre, Spain
Barcelona, , Spain
Madrid, , Spain
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
London, Greater London, United Kingdom
Manchester, Greater Manchester, United Kingdom
Sutton, Surrey, United Kingdom
Countries
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References
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Katakami N, Felip E, Spigel DR, Kim JH, Olivo M, Guo M, Nokihara H, Yang JC, Iannotti N, Satouchi M, Barlesi F. A randomized, open-label, multicenter, phase 3 study to compare the efficacy and safety of eribulin to treatment of physician's choice in patients with advanced non-small cell lung cancer. Ann Oncol. 2017 Sep 1;28(9):2241-2247. doi: 10.1093/annonc/mdx284.
Other Identifiers
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E7389-G000-302
Identifier Type: -
Identifier Source: org_study_id
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