A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Pati… (NCT02268851) | Clinical Trial Compass
CompletedPhase 1
A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
United States45 participantsStarted 2014-11
Plain-language summary
This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed diagnosis of Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL)
* Adequate organ system function ( Absolute neutrophil count, Platelets,Bilirubin, Platelets, Aspartate transferase ,Alanine aminotransferase, Creatinine Clearance)
* Eastern Cooperative Group (ECOG) Performance status ≤ 2
* Ability to swallow and retain oral medication
* Female patients: must have negative serum pregnancy test at study screening/ all male partners must consent to use a medically acceptable method of contraception
* Willingness and ability to comply with trial and follow-up procedures, and give written informed consent
Exclusion Criteria:-
* Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) within 3 weeks of Cycle 1/Day 1,
* Autologous hematologic stem cell transplant within 3 months of study entry.
* Allogeneic hematologic stem cell transplant within 12 months.
* Post-allo patients must not have active graft versus-host disease
* Evidence of active Hepatitis B,Hepatitis C or HIV infection.
* Active central nervous system involvement by lymphoma
* Requires treatment with strong CYP3A4/5 inhibitors
* Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* QTcF \>470 msec (QT interval, Fredericia calculation)
* Angina not well-controlled by me…
What they're measuring
1
Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I
Timeframe: Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I