Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer (PILOT)
This study is currently recruiting participants.
Verified March 2013 by Ganymed Pharmaceuticals AG
Sponsor:
Ganymed Pharmaceuticals AG
Information provided by (Responsible Party):
Ganymed Pharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT01671774
First received: August 21, 2012
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced gastroesophageal cancer. In case favorable effects of adding Zoledronic acid/Interleukin-2 are observed a third arm featuring IMAB362, EOX and Zoledronic Acid/Interleukin-2 may be started in a concomitant Phase II FAST trial (EudraCT 2011-005285-38) will start. The sponsor will provide an amended protocol including dosing details of IL-2 in case of a positive decision to start arm 3.
| Condition | Intervention | Phase |
|---|---|---|
|
CLDN18.2-positive Gastric Adenocarcinoma CLDN18.2-positive Adenocarcinoma of Esophagus CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction |
Drug: IMAB362 Drug: Zoledronic acid Drug: Interleukin-2 (1 million IU) Drug: Interleukin-2 (3 million IU) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter, Open-label, Exploratory Phase I Pilot Study to Investigate Safety, Pharmacodynamics and Pharmacokinetics of Immunological Effects and Activity of Combining Multiple Doses of IMAB362 With Immunomodulation (Zoledronic Acid, Interleukin-2) in Patients With Advanced Adenocarcinoma of the Stomach, the Lower Esophagus or the Gastro-esophageal Junction. |
Resource links provided by NLM:
Further study details as provided by Ganymed Pharmaceuticals AG:
Primary Outcome Measures:
- Safety and Tolerability [ Time Frame: at least 18 months ] [ Designated as safety issue: Yes ]Descriptive statistics for treatments will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
- Immune cell profile and kinetics [ Time Frame: at least 18 months ] [ Designated as safety issue: No ]Descriptive statistics for treatments will be given on the number and activity of immune cells in peripheral blood of patients.
Secondary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: at least 18 months ] [ Designated as safety issue: No ]PFS is defined as the time from registration of therapy to the first observation of disease progression or death from any cause or last tumor evaluation if free of progression. For patients who have not progressed either clinically or on the last scan, they will be censured as of the last tumor evaluation.
- Objective tumor response rate (ORR) [ Time Frame: at least 18 months ] [ Designated as safety issue: No ]ORR comprises the fraction of patients with CR, PR according to RECIST v1.1. It is set in relation to the ITT population and PP population.
- Disease control rate (DCR) [ Time Frame: at least 18 months ] [ Designated as safety issue: No ]DCR is defined as the fraction of patients with CR or PR or SD according to RECIST v1.1. It is set in relation to the ITT population and PP population.
- Duration of response (DOR) [ Time Frame: at least 18 months ] [ Designated as safety issue: No ]Duration of response is determined as the time when criteria for CR, PR, and SD are first met until the first date that recurrent or progressive disease or death occurs.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IMAB362 + ZA |
Drug: IMAB362
800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle
Drug: Zoledronic acid
4 mg on d 1 of cycle 1 and cycle 3
|
| Experimental: IMAB362 + ZA + IL-2 (1 million IU) |
Drug: IMAB362
800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle
Drug: Zoledronic acid
4 mg on d 1 of cycle 1 and cycle 3
Drug: Interleukin-2 (1 million IU)
1 million IU on day 1, 2 and 3 of cycles 1 and 3.
|
| Experimental: IMAB362 + ZA + IL-2 (3 million IU) |
Drug: IMAB362
800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle
Drug: Zoledronic acid
4 mg on d 1 of cycle 1 and cycle 3
Drug: Interleukin-2 (3 million IU)
3 million IU on day 1, 2 and 3 of cycles 1 and 3.
|
| Active Comparator: IMAB362 |
Drug: IMAB362
800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
- Inoperable locally advanced disease, resections with R0, R1 or R2 outcome or metastatic disease.
- CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
- Measurable and/or non-measurable disease as defined according to RECIST v1.1
- Age ≥ 18 years
- Written informed consent
- ECOG performance status (PS) 0-1
- Life expectancy > 3 months
Exclusion Criteria:
- Prior hypersensitivity reaction or intolerance to one of the compounds of the study treatment
- Known HIV infection or known symptomatic hepatitis (A, B, C)
- Clinical symptoms of cerebral metastases
- Pregnancy or breastfeeding
- Patients treated with any bisphosphonate-based therapeutic for any indication during the previous year
- Hypocalcemia that requires medication. Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL (3.0 mmol/L)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671774
Contacts
| Contact: Christian Müller | +49 (0)6131-62957-162 | c.mueller@ganymed.ag |
| Contact: Silke Essler, Dr. | +49 (0)6131-62957-173 | s.essler@ganymed.ag |
Locations
| Bulgaria | |
| Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology | Not yet recruiting |
| Plovdiv, Bulgaria, 4002 | |
| Contact: Velko Minchev, Dr. +359(32)990007 v_minchev@abv.bg | |
| Principal Investigator: Velko Minchev, Dr. | |
| University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia, Clinic of Medical Oncology | Not yet recruiting |
| Sofia, Bulgaria, 1527 | |
| Contact: Assen Dudov, Dr. +359(2)9432153 adudov@abv.bg | |
| Principal Investigator: Assen Dudov, Dr. | |
| Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Department of Medical Oncology | Not yet recruiting |
| Sofia, Bulgaria, 1606 | |
| Contact: Zhasmina Mihaylova, Dr. +359(2)9172744 zhasmina@yahoo.com | |
| Principal Investigator: Zhasmina Mihaylova, Dr. | |
| Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology | Not yet recruiting |
| Sofia, Bulgaria, 1303 | |
| Contact: Constanta Timcheva, Dr. +359(2)4889991 ctimcheva12@gmail.com | |
| Principal Investigator: Constanta Timcheva, Dr. | |
| Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology | Not yet recruiting |
| Varna, Bulgaria, 9010 | |
| Contact: Dimitar Kalev, Dr. +359(52)978388 dimitar@kalevi.eu | |
| Principal Investigator: Dimitar Kalev, Dr. | |
| Czech Republic | |
| University Hospital Olomouc, Clinic of Oncology | Not yet recruiting |
| OLomouc, Czech Republic, 77520 | |
| Contact: Bohuslav Melichar, Dr. +240(58)8444288 bohuslav.melichar@fnol.cz | |
| Principal Investigator: Bohuslav Melichar, Dr. | |
| University Hospital Motol, Department of Radiotherapy and Oncology | Recruiting |
| Prague, Czech Republic, 15006 | |
| Contact: Zdenek Linke, Dr. +240(58)224 431 111 cizinecke@fnmotol.cz | |
| Principal Investigator: Zdenek Linke, Dr. | |
| Hospital Znojmo, Department of Radiation and Clinical Oncology | Not yet recruiting |
| Znojmo, Czech Republic, 66902 | |
| Contact: Renata Neumanova, Dr. +240(51)5215141 renata.neumanova@nemzn.cz | |
| Principal Investigator: Renata Neumanova, Dr. | |
| Germany | |
| Institut für Klinische Forschung, Krankenhaus Nordwest GmbH | Recruiting |
| Frankfurt, Hessen, Germany, 60488 | |
| Contact: Salah-Eddin Al-Batran, PD Dr. med. +49 69 7601 4420 albatran@khnw.de | |
| Principal Investigator: Salah-Eddin Al-Batran, PD Dr. med. | |
| BAG / Onkologische Schwerpunktpraxis | Recruiting |
| Dresden, Sachsen, Germany, 01307 | |
| Contact: Jens Freiberg-Richter, Dr. med. +49 351 4400022 freiberg-richter@onkologie-dresden.net | |
| Principal Investigator: Jens Freiberg-Richter, Dr. med. | |
| Charité Universitätsmedizin Berlin - CVK, Med. Klinik m.S. Hämatologie und Onkologie | Recruiting |
| Berlin, Germany, 13353 | |
| Contact: Peter Thuss-Patience, Dr. med. +49 30 450 553 699 magenkarzinom@charite.de | |
| Principal Investigator: Peter Thuss-Patience, Dr. med. | |
| Freiburg University Medical Center, Department of Internal Medicine II, Gastroenterology and Hepatology | Recruiting |
| Freiburg, Germany, 79106 | |
| Contact: Volker Brass, Dr. +49 (761) 2703 3140 volker.brass@uniklinik-freiburg.de | |
| Principal Investigator: Volker Brass, Dr. med. | |
| University Hospital Halle (Saale), Department of Internal Medicine IV | Recruiting |
| Halle, Germany, 06120 | |
| Contact: Jörn Rüssel, Dr. +49(345)5572849 joern.ruessel@medizin.uni-halle.de | |
| Principal Investigator: Jörn Rüssel, Dr. med. | |
| Leipzig University Hospital, University Cancer Center (UCCL) | Recruiting |
| Leipzig, Germany, 04109 | |
| Contact: Florian Lordick, Dr. +49(341)9712572 studienzentrale.uccl@medizin.uni-leipzig.de | |
| Principal Investigator: Florian Lordick, Prof. Dr. | |
| University Hospital Tuebingen, Department of Internal Medicine I - Gastroenterology, Hepatology, Infectious Diseases | Recruiting |
| Tübingen, Germany, 72076 | |
| Contact: Michael Bitzer, Dr. +49 (7071) 298 0583 michael.bitzer@med.uni-tuebingen.de | |
| Principal Investigator: Michael Bitzer, Prof. Dr. | |
| Ulm University Hospital, Center for Internal Medicine | Recruiting |
| Ulm, Germany, 89070 | |
| Contact: Goetz von Wichert, Prof. Dr. +49 (731) 5004 4505 goetz.wichert@uniklinik-ulm.de | |
| Principal Investigator: Goetz von Wichert, Prof. Dr. | |
| Latvia | |
| Daugavpils Regional Hospital | Not yet recruiting |
| Daugavpils, Latvia, LV-5417 | |
| Contact: Marianna Bitina, Dr. +371(654)39529 mary-ann@nbox.lv | |
| Principal Investigator: Marianna Bitina, Dr. | |
| Piejuras Hospital, Oncology Clinic | Recruiting |
| Liepaja, Latvia, 3401 | |
| Contact: Anna Krilova, Dr. +347(634)25311 onk@e-liepaja.lv | |
| Principal Investigator: Anna Krilova, Dr. | |
| Riga East University Hospital, LLC, Latvian Oncology Center | Recruiting |
| Riga, Latvia, LV1038 | |
| Contact: Zanete Zvirbule, Dr. +371(6)7042281 Zzvirbule@nbo.lv | |
| Principal Investigator: Zanete Zvirbule, Dr. | |
Sponsors and Collaborators
Ganymed Pharmaceuticals AG
More Information
No publications provided
| Responsible Party: | Ganymed Pharmaceuticals AG |
| ClinicalTrials.gov Identifier: | NCT01671774 History of Changes |
| Other Study ID Numbers: | GM-IMAB-001-04, 2011-005509-64 |
| Study First Received: | August 21, 2012 |
| Last Updated: | March 27, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Interleukin-2 Zoledronic acid Diphosphonates Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 23, 2013