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| Sponsor: | Eisai Inc. |
|---|---|
| Collaborator: |
PharmaBio Development Inc. |
| Information provided by (Responsible Party): | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01133756 |
Purpose
The purpose of this study is to determine the MTD/recommended Phase II dose of E7080 administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and tolerability of E7080 administered in combination with carboplatin and gemcitabine compared to carboplatin and gemcitabine alone. (Phase II)
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: E7080 Drug: Carboplatin + Gemcitabine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125. |
| Enrollment: | 7 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: E7080
Carboplatin + Gemcitabine + E7080.
|
Drug: E7080
Test product: dose and mode of administration: E7080 will be provided as 1 mg, 4 mg, and 10 mg tablets. E7080 will be self-administered orally by patients, once-daily, over 3 weeks during each cycle. For the Phase Ib portion, the dose will be 16 mg, 20 mg, or 24 mg and for the Phase II portion, the dose will be the MTD as determined in the Phase Ib portion of the study. Number of cycles of E7080: until progression or unacceptable toxicity develops. Other Name: Gemzar; Paraplatin
Drug: Carboplatin + Gemcitabine
Comparator dose and mode of administration: Gemcitabine (1000 mg/m2) given by IV infusion over 30 minutes on Day 1 and Day 8 of a 21-day cycle. Carboplatin (AUC 4) given by IV infusion over 30 minutes on Day 1 of a 21-day cycle. Number of cycles: approximately 6. |
|
Active Comparator: 1
Carboplatin + Gemcitabine
|
Drug: Carboplatin + Gemcitabine
Comparator dose and mode of administration: Gemcitabine (1000 mg/m2) given by IV infusion over 30 minutes on Day 1 and Day 8 of a 21-day cycle. Carboplatin (AUC 4) given by IV infusion over 30 minutes on Day 1 of a 21-day cycle. Number of cycles: approximately 6. |
This open-label, multicenter, randomized study will consist of a Phase Ib portion: a safety run-in period with 3 ascending doses of E7080 administered in combination with carboplatin + gemcitabine; and a Phase II portion: a randomized 2-arm period. Approximately 100 patients with ovarian cancer will be enrolled in the study (10-20 patients in the Phase Ib portion and 80 patients in the Phase II portion). Patients will only participate in either the Phase Ib or the Phase II portion. Patients will receive study treatment (E7080 plus carboplatin + gemcitabine or carboplatin + gemcitabine) for approximately six 21-day cycles (18 weeks). Patients who receive E7080 and experience evidence of clinical benefit (CR, PR, or SD) may continue single agent E7080 beyond 18 weeks, until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or withdrawal by investigator, whichever occurs first.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects may be in the study only if they meet all of the following criteria.
Documentation of biochemical relapse defined by CA125 criteria (measurable or non-measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST criteria), more than six months since completion of first-line platinum-based chemotherapy requiring treatment with further platinum-based chemotherapy. CA125 criteria for relapse Gynecologic Cancer Intergroup (GCIG) criteria are the finding of 2 serum CA125 levels with samples taken at least 1 week apart and no greater than 3 months apart:
Adequate hematologic, renal, liver, and coagulation system function as defined by laboratory values performed within 21 days prior to initiation of dosing.
Exclusion Criteria:
Patients will not be entered in the study for any of the following reasons:
Contacts and Locations| United States, California | |
| Bay Area Cancer Research Group | |
| Concord, California, United States, 94520 | |
| United States, Colorado | |
| Rocky Mountain Gynecologic Oncology | |
| Englewood, Colorado, United States, 80113 | |
| United States, Maryland | |
| David Smith | |
| Easton, Maryland, United States, 21601 | |
| United States, Texas | |
| Texas Oncology - Austin Central | |
| Austin, Texas, United States, 78731 | |
| Italy | |
| Azienda Ospedaliera Universitaria di Modena | |
| Modena, MO, Italy | |
| Azienda Ospedaliero Universitaria Consorziale Policlinico di | |
| Bari, Italy, 70124 | |
| Azienda Ospedaliera Istituti Ospitalieri di Cremona | |
| Cremona, Italy, 26100 | |
| Ente Ospedaliero Ospedali Galliera | |
| Genoa, Italy | |
| IEO Istituto Europeo di Oncologia | |
| Milan, Italy, 20141 | |
| Poland | |
| Sp ZOZ Wojewodzki Szpital Specjalistyczny nr 4 | |
| Bytom, Poland, 41-902 | |
| Centrum Onkologii Ziemi Lubelskiej | |
| Lublin, Poland, 20-090 | |
| Wielkopolskie Centrum Onkologii | |
| Poznan, Poland, 61-866 | |
| NZOZ Centrum Medyczne Onkologii i Hipertermii, | |
| Warszawa, Poland, 02-793 | |
| Centrum Onkologii-Instytut im. M. Sklodowskiej Curie | |
| Warszawa, Poland, 02-781 | |
| Russian Federation | |
| Arkhangelsk Regional Clinical Oncology Dispensary | |
| Arkhangelsk, Russian Federation, 163045 | |
| S.I. Russian Oncological Research Center n.a. N.N. Blokhin | |
| Moscow, Russian Federation, 115478 | |
| Pyatigorsky Oncologic Dispensary | |
| Pyatigorsk, Russian Federation, 357502 | |
| Oncology Dispensary #2 of Krasnodar Region | |
| Sochi, Russian Federation, 354057 | |
| St.-Petersburg City Oncology Dispensary | |
| St.-Petersburg, Russian Federation, 198255 | |
| Yaroslav Regional Clinical Oncology Hospital | |
| Yaroslav, Russian Federation, 150054 | |
| Ukraine | |
| Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU | |
| Dnipropetrovsk, Ukraine, 49102 | |
| Donetsk Regional Antitumor Center | |
| Donetsk, Ukraine, 83092 | |
| The St.Inst. "S.P.Grigoriev Med. Rad.Inst. of AMS of Ukr." | |
| Kharkiv, Ukraine, 61024 | |
| Volyn regional oncological center | |
| Lutsk, Ukraine, 43018 | |
| Vinnytsya Reg. Clin. Oncological Dispansary | |
| Vinnytsya, Ukraine, 21018 | |
| Study Director: | Harish Dave, MD | Quintiles |
More Information
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01133756 History of Changes |
| Other Study ID Numbers: | E7080-701, EURDACT NO 2009-016050-41 |
| Study First Received: | May 21, 2010 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Gemcitabine Carboplatin |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |