A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01774786
First received: January 21, 2013
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab), fluoropyrimidine and cisplatin as first-line treatment in patients with HER2-positive metastatic gastroesophageal junction or gastric cancer. Patients will be randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in combination with Herceptin (initial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Patients will continue to receive Perjeta or placebo and Herceptin until disease progression or unacceptable toxicity occurs.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: pertuzumab [Perjeta] Drug: placebo Drug: trastuzumab [Herceptin] Drug: cisplatin Drug: capecitabine Drug: 5-fluorouracil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC GASTROESOPHAGEAL JUNCTION OR GASTRIC CANCER |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Overall survival: Time from randomization to death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival: Time from randomization to first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria, or death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
- Overall objective response (partial response + complete response) occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST v1.1 criteria [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
- Duration of objective response: Time from occurrence of objective response to progressive disease, as determined by investigator according to RECIST v1.1 criteria, or death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
- Clinical benefit rate: Best response of complete response or partial response or stable disease for 6 weeks or longer, as determined by the investigator according to RECIST v1.1 criteria [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
- Safety: Incidence of left ventricular systolic dysfunction (symptomatic or asymptomatic) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 780 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pertuzumab + TFP |
Drug: pertuzumab [Perjeta]
840 mg iv every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv initial dose on Day 1, followed by 6 mg/kg iv every 3 weeks
Drug: cisplatin
80 mg/m2 iv every 3 weeks, 6 cycles
Drug: capecitabine
1000 mg/m2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) every 3 weeks, 6 cycles (or 5-fluorouracil)
Drug: 5-fluorouracil
800 mg/m2/24 hours iv by continuous infusion for 120 hours (Days 1-5) every 3 weeks, 6 cycles (or capecitabine)
|
| Placebo Comparator: Placebo + TFP |
Drug: placebo
pertuzumab placebo iv every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv initial dose on Day 1, followed by 6 mg/kg iv every 3 weeks
Drug: cisplatin
80 mg/m2 iv every 3 weeks, 6 cycles
Drug: capecitabine
1000 mg/m2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) every 3 weeks, 6 cycles (or 5-fluorouracil)
Drug: 5-fluorouracil
800 mg/m2/24 hours iv by continuous infusion for 120 hours (Days 1-5) every 3 weeks, 6 cycles (or capecitabine)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction
- Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy >/= 3 months
Exclusion Criteria:
- Previous cyctotoxic chemotherapy for advanced (metastatic) disease
- Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
- Previous treatment with any HER2-directed therapy, at any time, for any duration
- Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
- Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to peripheral bone metastases, if recovered from all toxicities)
- History or evidence of brain metastases
- Clinically significant active GI bleeding (Grade >/= 2 according to NIC-CTCAEv.4.03)
- Other malignancy (in addition to GC) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
- Inadequate hematologic, renal or liver function
- Pregnant or lactating women
- History of congestive heart failure of any New York Heart Association (NYHA) criteria
- Angina pectoris requiring treatment
- Myocardial infarction within the past 6 months before the first dose of study drug
- Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
- History or evidence of poorly controlled hypertension
- Baseline left ventricular ejection fraction (LVEF) value < 55%
- Any significant uncontrolled intercurrent systemic illness
- Positive for hepatitis B, hepatitis C or HIV infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774786
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Contacts
| Contact: Please reference Study ID Number: BO25114 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, Colorado | |
| Not yet recruiting | |
| Denver, Colorado, United States, 80218 | |
| United States, Illinois | |
| Not yet recruiting | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Not yet recruiting | |
| Goshen, Indiana, United States, 46526 | |
| United States, Minnesota | |
| Not yet recruiting | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Nevada | |
| Not yet recruiting | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New York | |
| Not yet recruiting | |
| Albany, New York, United States, 12206 | |
| Not yet recruiting | |
| Fresh Meadows, New York, United States, 11366 | |
| United States, South Carolina | |
| Not yet recruiting | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Not yet recruiting | |
| Fort Worth, Texas, United States, 76177 | |
| Not yet recruiting | |
| Lewisville, Texas, United States, 75067 | |
| Not yet recruiting | |
| Paris, Texas, United States, 75460 | |
| Not yet recruiting | |
| Tyler, Texas, United States, 75702 | |
| United States, Virginia | |
| Not yet recruiting | |
| Fairfax, Virginia, United States, 22031 | |
| United States, Washington | |
| Not yet recruiting | |
| Tacoma, Washington, United States, 98405 | |
| Australia | |
| Recruiting | |
| East Bentleigh, Australia, VIC 3165 | |
| Recruiting | |
| Heidelberg, Australia, 3084 | |
| Recruiting | |
| Herston, Australia, 4029 | |
| Not yet recruiting | |
| Perth, Australia, 6009 | |
| Austria | |
| Not yet recruiting | |
| Salzburg, Austria, 5020 | |
| Not yet recruiting | |
| Zams, Austria, 6511 | |
| Belgium | |
| Not yet recruiting | |
| Bruxelles, Belgium, 1200 | |
| Not yet recruiting | |
| Leuven, Belgium, 3000 | |
| Brazil | |
| Not yet recruiting | |
| Florianopolis, Brazil, 88034-000 | |
| Not yet recruiting | |
| Porto Alegre, Brazil, 91350-200 | |
| Not yet recruiting | |
| Porto Alegre, Brazil, 90450-071 | |
| Not yet recruiting | |
| Rio de Janeiro, Brazil, 22631-004 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 04039-030 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 01509-010 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 01406-000 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 01308-050 | |
| Canada, Newfoundland and Labrador | |
| Not yet recruiting | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Ontario | |
| Not yet recruiting | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Not yet recruiting | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Not yet recruiting | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Not yet recruiting | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Canada, Quebec | |
| Not yet recruiting | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Croatia | |
| Not yet recruiting | |
| Osijek, Croatia, 31000 | |
| Not yet recruiting | |
| Zagreb, Croatia, 10000 | |
| El Salvador | |
| Not yet recruiting | |
| El Salvador, El Salvador, 01101 | |
| Finland | |
| Not yet recruiting | |
| Helsinki, Finland, 00180 | |
| Not yet recruiting | |
| Turku, Finland, 20521 | |
| Germany | |
| Not yet recruiting | |
| Berlin, Germany, 13353 | |
| Not yet recruiting | |
| Essen, Germany, 45136 | |
| Not yet recruiting | |
| Esslingen, Germany, 79730 | |
| Not yet recruiting | |
| Hamburg, Germany, 20246 | |
| Not yet recruiting | |
| Leipzig, Germany, 04103 | |
| Not yet recruiting | |
| Ludwigsburg, Germany, 71540 | |
| Not yet recruiting | |
| Mainz, Germany, 55131 | |
| Not yet recruiting | |
| Mannheim, Germany, 68167 | |
| Not yet recruiting | |
| Marburg, Germany, 35043 | |
| Not yet recruiting | |
| ULM, Germany, 89081 | |
| Guatemala | |
| Not yet recruiting | |
| Guatemala, Guatemala, 01-010 | |
| Hungary | |
| Not yet recruiting | |
| Budapest, Hungary, 1122 | |
| Not yet recruiting | |
| Budapest, Hungary, 1082 | |
| Not yet recruiting | |
| Debrecen, Hungary, 4012 | |
| Not yet recruiting | |
| Szeged, Hungary, 6720 | |
| Italy | |
| Not yet recruiting | |
| Ancona, Italy | |
| Not yet recruiting | |
| Bergamo, Italy, 24127 | |
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| Bologna, Italy, 40138 | |
| Not yet recruiting | |
| Catanzaro, Italy, 88100 | |
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| Genova, Italy, 16132 | |
| Not yet recruiting | |
| Milano, Italy, 20132 | |
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| Milano, Italy, 20141 | |
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| Napoli, Italy, 80131 | |
| Recruiting | |
| Pisa, Italy, 56100 | |
| Recruiting | |
| Prato, Italy, 59100 | |
| Not yet recruiting | |
| Reggio Emilia, Italy, 42100 | |
| Not yet recruiting | |
| Roma, Italy, 00168 | |
| Not yet recruiting | |
| San Giovanni Rotondo, Italy, 71013 | |
| Not yet recruiting | |
| Udine, Italy, 33100 | |
| Japan | |
| Not yet recruiting | |
| Aichi, Japan, 464-8681 | |
| Not yet recruiting | |
| Ehime, Japan, 791-0280 | |
| Not yet recruiting | |
| Fukuoka, Japan, 812-8582 | |
| Not yet recruiting | |
| Gifu, Japan, 501-1194 | |
| Not yet recruiting | |
| Hiroshima, Japan, 730-8518 | |
| Not yet recruiting | |
| Kanagawa, Japan, 216-8511 | |
| Not yet recruiting | |
| Kanagawa, Japan, 241-8515 | |
| Not yet recruiting | |
| Osaka, Japan, 537-8511 | |
| Korea, Republic of | |
| Not yet recruiting | |
| Daegu, Korea, Republic of, 702-210 | |
| Recruiting | |
| Seoul, Korea, Republic of, 138-736 | |
| Recruiting | |
| Seoul, Korea, Republic of, 120-752 | |
| Recruiting | |
| Seoul, Korea, Republic of, 135-710 | |
| Not yet recruiting | |
| Seoul, Korea, Republic of, 137-807 | |
| Recruiting | |
| Seoul, Korea, Republic of, 110-744 | |
| Macedonia, The Former Yugoslav Republic of | |
| Not yet recruiting | |
| Bitola, Macedonia, The Former Yugoslav Republic of, 7000 | |
| Not yet recruiting | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Malaysia | |
| Not yet recruiting | |
| Kelantan, Malaysia, 16150 | |
| Not yet recruiting | |
| Kuala Lumpur, Malaysia, 59100 | |
| Not yet recruiting | |
| Kuala Lumpur, Malaysia, 50586 | |
| Not yet recruiting | |
| Sabah, Malaysia, 88996 | |
| Mexico | |
| Not yet recruiting | |
| Mexico City, Mexico, 14000 | |
| Not yet recruiting | |
| Mexico City, Mexico, 06760 | |
| Not yet recruiting | |
| Oaxaca, Mexico, 68000 | |
| Netherlands | |
| Not yet recruiting | |
| Amsterdam, Netherlands, 1105 AZ | |
| Panama | |
| Not yet recruiting | |
| Panama, Panama | |
| Peru | |
| Not yet recruiting | |
| Arequipa, Peru, 5154 | |
| Not yet recruiting | |
| Lima, Peru, 41 | |
| Not yet recruiting | |
| Lima, Peru, Lima 27 | |
| Not yet recruiting | |
| Miraflores, Peru, Lima 18 | |
| Not yet recruiting | |
| Piura, Peru, 20011 | |
| Poland | |
| Not yet recruiting | |
| Bialystok, Poland, 15-027 | |
| Not yet recruiting | |
| Brzozów, Poland, 36-200 | |
| Not yet recruiting | |
| Opole, Poland, 45-060 | |
| Not yet recruiting | |
| Warszawa, Poland, 02-781 | |
| Not yet recruiting | |
| Wroclaw, Poland, 53-413 | |
| Romania | |
| Not yet recruiting | |
| Bucharest, Romania, 022328 | |
| Not yet recruiting | |
| Cluj-napoca, Romania, 400015 | |
| Not yet recruiting | |
| Craiova, Romania, 200385 | |
| Russian Federation | |
| Not yet recruiting | |
| Omsk, Russian Federation, 644013 | |
| Not yet recruiting | |
| Samara, Russian Federation, 443066 | |
| Spain | |
| Recruiting | |
| Barcelona, Spain, 08003 | |
| Not yet recruiting | |
| Barcelona, Spain, 08916 | |
| Not yet recruiting | |
| Barcelona, Spain, 08025 | |
| Recruiting | |
| Barcelona, Spain, 08035 | |
| Not yet recruiting | |
| Cordoba, Spain, 14004 | |
| Not yet recruiting | |
| Elche, Spain, 03203 | |
| Not yet recruiting | |
| Madrid, Spain, 28034 | |
| Switzerland | |
| Not yet recruiting | |
| Lausanne, Switzerland, 1011 | |
| Recruiting | |
| Luzern, Switzerland, 6004 | |
| Not yet recruiting | |
| Zürich, Switzerland, 8063 | |
| Taiwan | |
| Not yet recruiting | |
| Tainan, Taiwan, 704 | |
| Not yet recruiting | |
| Taipei, Taiwan, 00112 | |
| Not yet recruiting | |
| Taipei, Taiwan, 106 | |
| Not yet recruiting | |
| Taoyuan, Taiwan, 333 | |
| Thailand | |
| Not yet recruiting | |
| Bangkok, Thailand, 10700 | |
| Not yet recruiting | |
| Bangkok, Thailand, 10400 | |
| Not yet recruiting | |
| Khonkaen, Thailand, 40000 | |
| Not yet recruiting | |
| Patumwan, Thailand, 10330 | |
| Not yet recruiting | |
| Songkhla, Thailand, 90110 | |
| Turkey | |
| Not yet recruiting | |
| Ankara, Turkey, 06590 | |
| Not yet recruiting | |
| Antalya, Turkey, 07070 | |
| Not yet recruiting | |
| Edirne, Turkey, 22770 | |
| Not yet recruiting | |
| Erzurum, Turkey, 25240 | |
| Not yet recruiting | |
| Istanbul, Turkey, 34300 | |
| Not yet recruiting | |
| Konya, Turkey, 42080 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01774786 History of Changes |
| Other Study ID Numbers: | BO25114 |
| Study First Received: | January 21, 2013 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Trastuzumab Capecitabine Cisplatin |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013