Phase 1
Completed N=43
A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
Source: ClinicalTrials.gov NCT02268851 ↗Enrolled (actual)
43
Serious AEs
27.9%
Results posted
Jun 2020
Primary outcomePrimary: Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Overall Response Rate (ORR) |
95.2; 71.4 | — |
| SECONDARY Rate of Nodal Partial Response With Lymphocytosis (nPR) |
71.4 | — |
| SECONDARY Median Progression-Free Survival (PFS) |
82.66; 26.87 | — |
| SECONDARY Median Duration of Overall Response (DOR) |
80.36; 42.32 | — |
Eligibility Criteria
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 medication
- Poorly controlled or clinically significant atherosclerotic vascular disease
- Presence of other active cancers, or history of treatment for invasive cancer within the past 2 years.
- Require warfarin for anticoagulation
- Women who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT02268851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.