Continuation of treatment for cancer patients from previous studies
An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study
PHASE3 · Hoffmann-La Roche · NCT05862285
This study is testing if cancer patients who have been part of earlier research can continue receiving treatment with new medications to see if it helps them keep feeling better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Hoffmann-La Roche (industry) |
| Locations | 58 sites (Charleroi and 57 other locations) |
| Trial ID | NCT05862285 on ClinicalTrials.gov |
What this trial studies
This extension study aims to provide ongoing treatment with Roche investigational medicinal products or comparator agents for cancer patients who were previously enrolled in Genentech or Roche-sponsored studies. Eligible participants will receive either monotherapy or combination therapy based on their prior treatment and current needs. The study is designed for those who are still benefiting from their treatment and do not have local access to these investigational therapies. The first dose in this extension will be administered within a week of the treatment interruption from the parent study.
Who should consider this trial
Good fit: Ideal candidates are cancer patients who were previously enrolled in a Roche or Genentech study and are still benefiting from the investigational treatment.
Not a fit: Patients who have discontinued treatment due to adverse effects or who have access to commercially available treatments in their country may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could ensure continued access to potentially effective cancer treatments for patients who have shown benefit in prior studies.
How similar studies have performed: Other studies have successfully provided continued treatment options for patients transitioning from clinical trials, indicating a positive precedent for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol OR * Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent * First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study * Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator * Ability to comply with the extension study protocol, per Investigator's judgement Exclusion Criteria: * Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study * Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant * Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study * Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable) * Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study * Concurrent participation in any therapeutic clinical trial (other than the parent study)
Where this trial is running
Charleroi and 57 other locations
- GHdC Site Les Viviers — Charleroi, Belgium (COMPLETED)
- AZ Groeninge — Kortrijk, Belgium (ACTIVE_NOT_RECRUITING)
- UZ Leuven Gasthuisberg — Leuven, Belgium (COMPLETED)
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (RECRUITING)
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University — XI 'an City, Shaanxi Province, Shaanxi, China (RECRUITING)
- Beijing Cancer Hospital — Beijing, China (RECRUITING)
- the First Hospital of Jilin University — Changchun, China (RECRUITING)
- West China Hospital of Sichuan University — Chengdu, China (RECRUITING)
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University — Hangzhou, China (RECRUITING)
- Harbin Medical University Cancer Hospital — Harbin, China (RECRUITING)
- The Second Affiliated Hospital of Anhui Medical University — Hefei, China (RECRUITING)
- Meizhou People's Hospital — Meizhou, China (RECRUITING)
- The 1st Affiliated Hospital of Nanchang Unversity — Nanchang, China (RECRUITING)
- Jiangsu Province Hospital of Chinese Medicine — Nanjing, China (RECRUITING)
- Fudan University Shanghai Cancer Center — Shanghai, China (RECRUITING)
- Shanghai Geriatric Medical Center — Shanghai, China (RECRUITING)
- The First Affiliated Hospital of Xiamen University — Xiamen, China (RECRUITING)
- The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, China (RECRUITING)
- Henan Cancer Hospital — Zhengzhou, China (RECRUITING)
- Clinica CIMCA — San José, Costa Rica (ACTIVE_NOT_RECRUITING)
- ICIMED Instituto de Investigación en Ciencias Médicas — San José, Costa Rica (ACTIVE_NOT_RECRUITING)
- Institut Bergonie — Bordeaux, France (RECRUITING)
- Centre Francois Baclesse — Caen, France (RECRUITING)
- Institut de Cancérologie de Bourgogne — Dijon, France (RECRUITING)
- Centre Leon Berard — Lyon, France (RECRUITING)
- Hopital de la Timone — Marseille, France (RECRUITING)
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque — Montpellier, France (RECRUITING)
- Institut de cancerologie du Gard — Nîmes, France (ACTIVE_NOT_RECRUITING)
- Hopital Tenon — Paris, France (RECRUITING)
- ICO - Site René Gauducheau — Saint-Herblain, France (RECRUITING)
- Institut Claudius Regaud — Toulouse, France (RECRUITING)
- Gustave Roussy — Villejuif, France (RECRUITING)
- General Hospital "G.Papanikolaou" — Asvestochóri, Greece (RECRUITING)
- Metropolitan General Hospital — Cholargós, Greece (RECRUITING)
- Kyushu University Hospital — Fukuoka, Japan (RECRUITING)
- Yokohama City University Medical Center — Kanagawa, Japan (ACTIVE_NOT_RECRUITING)
- Kanagawa Cancer Center — Kanagawa, Japan (COMPLETED)
- National Cancer Center Hospital East — Kashiwa-shi, Japan (RECRUITING)
- Saitama Cancer Center — Saitama, Japan (RECRUITING)
- NHO Kinki-Chuo Chest Medical Center — Sakaishi, Japan (RECRUITING)
- Centro Medico Culiacan SA de CV — Culiacán, Sinaloa, Mexico (ACTIVE_NOT_RECRUITING)
- Medical Care & Research — Mérida, Yucatán, Mexico (COMPLETED)
- Consultorio de Especialidad en Urologia Privado — Durango, Mexico (ACTIVE_NOT_RECRUITING)
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie — Warsaw, Poland (RECRUITING)
- Moscow City Oncology Hospital #62 — Moscovskaya Oblast, Moscow Oblast, Russia (RECRUITING)
- Russian Scientific Center of Roentgenoradiology — Moscow, Moscow Oblast, Russia (ACTIVE_NOT_RECRUITING)
- P.A. Herzen Oncological Inst. — Moscow, Moscow Oblast, Russia (RECRUITING)
- Seoul National University Bundang Hospital — Seongnam-si, South Korea (COMPLETED)
- Asan Medical Center — Seoul, South Korea (ACTIVE_NOT_RECRUITING)
- Taichung Veterans General Hospital — Taichung, Taiwan (RECRUITING)
+8 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Reference Study ID Number: BX44273 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer