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Clinical Trials/EUCTR2016-004356-30-ES
EUCTR2016-004356-30-ES
Active, not recruiting
Phase 1

Extended treatment protocol for subjects continuing to benefit from ibrutinib after completion of ibrutinib clinical trials

Pharmacyclics Switzerland GmbH0 sites500 target enrollmentApril 18, 2018
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ConditionsCLL, SLL, MCL, WM, DLBCL, FL, MZL, multiple myeloma, GvHD, pancreatic cancer, kidney cancer, bladder cancer, stomach cancer, throat cancer, colon cancerMedDRA version: 20.0Level: PTClassification code 10043515Term: Throat cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10054695Term: Waldenstrom's macroglobulinemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10042080Term: Stomach cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benTherapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
CLL, SLL, MCL, WM, DLBCL, FL, MZL, multiple myeloma, GvHD, pancreatic cancer, kidney cancer, bladder cancer, stomach cancer, throat cancer, colon cancer
Sponsor
Pharmacyclics Switzerland GmbH
Enrollment
500
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 18, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do no thave access to commercial ibrutinib within their region (eg, no regulatory approval ,insufficient reimbursement, and/or insufficient insurer coverage for the indication).
  • •2\. Ongoing continuous treatment with ibrutinib: ibrutinib treatment may be on temporary hold at the time of enrollment with less than 28 continuous doses missed, however, the decision cannot have been made to permanently discontinue ibrutinib treatment.
  • •3\. Subject must have completed all assessments in their parent protocol (eg, End\-of\-Treatment Visit is completed) and want to continue treatment with ibrutinib.
  • •4\.Subject has provided informed consent to the long\-term treatment extension protocol and not withdrawn consent from the parent study.
  • •5\.Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control (as desribed in the protocol) during the period of therapy and for 90 days for females and males after the last dose of drug.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 250
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •1\. Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.
  • •2\. Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol.
  • •3\. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment. Male subjects who plan to father a child while enrolled in this protocol or within 90 days after the last dose of drug treatment.
  • •4\. Unwilling or unable to participate in all required evaluations and procedures.
  • •5\. Unable to understand the purpose and risks of the protocol and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information(in accordance with national and local subject privacy regulations).

Outcomes

Primary Outcomes

Not specified

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