A Roll Over Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
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| ClinicalTrials.gov Identifier: NCT03194893 |
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Recruitment Status :
Recruiting
First Posted : June 21, 2017
Last Update Posted : December 9, 2019
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neoplasms | Drug: Alectinib Drug: Crizotinib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer |
| Actual Study Start Date : | July 5, 2017 |
| Estimated Primary Completion Date : | June 12, 2024 |
| Estimated Study Completion Date : | June 12, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Alectinib
Participants will receive alectinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
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Drug: Alectinib
Alectinib capsules 600 mg twice a day (BID) orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first. |
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Experimental: Crizotinib
Participants will receive crizotinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
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Drug: Crizotinib
Crizotinib capsules 250 mg BID orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first. |
Primary Outcome Measures :
- Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest [ Time Frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment) ]An AE is considered any unfavorable and unintended sign, symptom, or disease associated with use of study drug, whether or not considered related to study drug. Preexisting conditions that worsened during study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug is reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse events of special interest are cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice and suspected transmission of an infectious agent by study drug.
- Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters [ Time Frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment) ]Selected safety laboratory parameters include alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, alkaline phosphatase (ALP), and blood creatine phosphokinase (CPK). Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy is considered clinically significant.
Secondary Outcome Measures :
- Number and Causes of Death Occurring on Study [ Time Frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment) ]Once a patient has permanently discontinued study drug and completed the safety follow-up visit, no further survival data will be collected.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible
- Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form (eCRF)
- For women who are not postmenopausal (≥ 12 months of non−therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug
- For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.
Exclusion Criteria:
- Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study
- Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study
- Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation
- Pregnant or breastfeeding women
- Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study
- Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator
- Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the participant before trial entry
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194893
Contacts
| Contact: Reference Study ID Number: BO39694 www.roche.com/about_roche/roche_worldwide.htm | +1 888-662-6728 | global-roche-genentech-trials@gene.com |
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT03194893 History of Changes |
| Other Study ID Numbers: |
BO39694 2017-000207-24 ( EudraCT Number ) |
| First Posted: | June 21, 2017 Key Record Dates |
| Last Update Posted: | December 9, 2019 |
| Last Verified: | December 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Hoffmann-La Roche:
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Non−small cell lung cancer (NSCLC) Anaplastic lymphoma kinase (ALK) Rearranged during transfection (RET) Alectinib Crizotinib |
Additional relevant MeSH terms:
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Crizotinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |