E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastasized oesophagogastric carcinoma |
Gemetastaseerd oesophagus-maagcarcinoom |
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E.1.1.1 | Medical condition in easily understood language |
Generalized oesophagogastric cancer |
Uitgezaaide slokdarm-maagkanker |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Phase 1: To assess the safety and tolerability of Nab-paclitaxel added to oxaliplatin and capecitabine at their currently optimal doses.
Phase 2: To determine the anti-tumor activity of Nab-paclitaxel when co-administered with oxaliplatin and capecitabine in patients with irresectable or metastasized oesophagogastric cancer in terms of progression free survival.
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Fase 1: Beoordelen van de veiligheid en verdraagzaamheid van nab-paclitaxel toegevoegd aan oxaliplatin en capecitabine op hun huidige optimale dosering
Fase 2: Bepaling van de anti-tumor activiteit van nab-paclitaxel wanneer toegediend met oxaliplatin en capecitabine bij patiënten met gevorderd slokdarm-maagkanker in termen van progressievrije overleving.
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E.2.2 | Secondary objectives of the trial |
Phase 1: 1. To assess the number of complete cycles of Nab-paclitaxel, oxaliplatin and capecitabine delivered.
2. To assess response rate, progression free survival, overall survival.
3. To assess self-reported neurotoxicity.
Phase 2: 1. To assess the number of complete cycles of Nab-paclitaxel, oxaliplatin and capecitabine delivered.
2. To assess response rate, overall survival.
3. To assess self-reported neurotoxicity. |
Fase 1: 1. Beoordelen van het aantal toegediende cycli nab-paclitaxel, oxaliplatin en capecitabine
2. Beoordelen van de respons rate, progressievrije overleving en totale overleving
3. Beoordelen van zelfgerapporteerde neurotoxiciteit
Fase 2: 1. Beoordelen van het aantal toegediende cycli nab-paclitaxel, oxaliplatin en capecitabine
2. Beoordelen van de respons rate, progressievrije overleving en totale overleving
3. Beoordelen van zelfgerapporteerde neurotoxiciteit |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female ≥ 18 year
2. Histological proof of metastastic or irresectable carcinoma of the stomach or oesophagus.
3. WHO 0-2.
4. Measureable disease as assessed by RECIST 1.1
5. Adequate bone marrow and organ function.
6. Informed consent.
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1. Man of vrouw ≥ 18 jaar
2. Histologische bewijs van gemetastaseerd of irresectabele carcinoom van de maag of slokdarm.
3. WHO 0-2.
4. Meetbare ziekte zoals beoordeeld door RECIST 1.1
5. Voldoende beenmerg en orgaanfuncties.
6. Informed consent.
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E.4 | Principal exclusion criteria |
1. Prior systemic treatment for metastatic or irresectable stomach or oesophageal cancer
2. All target lesions in a radiation field without documented disease progressionn
3. WHO 3-4.
4. Use of other investigational drugs within 30 days of enrollment or 5 half-lives of the study drug, whichever is longer.
5. CNS metastases or a CNS malignancy.
6. Other previous malignancies except cervical carcinoma and squamous carcinoma of the skin ≥ 5 years ago |
1. Voorafgaand systemische behandeling voor uitgezaaide of irresectabele maag-of slokdarmkanker
2. Alle te vervolgen lesies in een stralingsveld zonder gedocumenteerde ziekteprogressie.
3. WHO 3-4.
4. Gebruik van andere geneesmiddelen voor onderzoek binnen 30 dagen na de inschrijving of 5 halfwaardetijden van de studie drug, als dat langer is.
5. CZS metastasen of een CNS maligniteit.
6. Andere eerdere maligniteiten behalve baarmoederhalskanker en plaveiselcelcarcinoom van de huid ≥ 5 jaar geleden. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Phase 1: (dose limiting toxicity) and MTD (maximum tolerated dose) of nab-paclitaxel co-administered with fixed doses of capecitabine and oxaliplatin in patients with metastatic or irresectable carcinoma of the stomach or oesophagus.
Phase 2: Progression free survival |
Fase 1: DLT (dosis-limiterende toxiciteit) en MTD (maximaal getolereerde dosis) van nab-paclitaxel toegediend met vaste doses van capecitabine en oxaliplatin bij patiënten met gevorderd slokdarm-maagkanker
Fase 2: progressie vrije overleving |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Phase 1: Continuously during treatment
Phase 2: Every nine (9) weeks |
Fase 1: Continue gedurende de behandeling
Fase 2: Elke negen (9) weken |
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E.5.2 | Secondary end point(s) |
Phase 1:
1. Adverse events, serious adverse events according to NCI CTC version 4.0
2. Response rate according to RECIST 1.1
3. Progression free survival and overall survival
4. Self-reported neurotoxicity according to the EORTC QLQ CIPN2019
Phase 2:
1. Adverse events, serious adverse events according to NCI CTC version 4.0
2. Response rate according to RECIST 1.1
3. Progression free survival and overall survival
4. Self-reported neurotoxicity according to the EORTC QLQ CIPN20 |
Fase 1:
1. Bijwerkingen, ernstige bijwerkingen volgens NCI CTC versie 4.0
2. Respons volgens RECIST 1.1
3. Progressievrije overleving en algehele overleving
4. Zelfgerapporteerde neurotoxiciteit volgens de EORTC QLQ CIPN2019
Fase 2:
1. Bijwerkingen, ernstige bijwerkingen volgens NCI CTC versie 4.0
2. Respons volgens RECIST 1.1
3. Totale overleving
4. Zelfgerapporteerde neurotoxiciteit volgens de EORTC QLQ CIPN20 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Phase 1: Continuously during treatment
Phase 2: everynine (9) weeks |
Fase 1: Continue gedurende de behandeling
Fase 2: Elke negen (9) weken |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
To determine the MTD (maximum tolerated dose) of the IMP |
Om de maximaal toelaatbare dosis te bepalen van de onderzoeksmedicatie |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Zonder de toevoeging van Nab-paclitaxel (Abraxane) |
Withouth the addition of Nab-paclitaxel (Abraxane) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |