Clinical trial · Interventional
Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
NCT01767766CI-TRIAL-00053438completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TGR-1202 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TGR-1202
- description
- TGR-1202 Daily Oral Dose
- interventionNames
- Drug: TGR-1202
Primary outcomes (1)
- measure
- Maximum Tolerated Dose acceptable for participants
- timeFrame
- 28 days (1 cycle of therapy)
- description
- To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Secondary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Up to 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Refractory to or relapsed after at least 1 prior treatment regimen; * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2; * At least 18 years of age. Exclusion Criteria: * Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks); * Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months; * Known hepatitis B virus, hepatitis C virus or HIV infection; * Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;
References
Publications (1)
- DERIVEDBurris HA 3rd, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, Gutierrez M, Essell JH, Kuhn JG, Miskin HP, Sportelli P, Weiss MS, Vakkalanka S, Savona MR, O'Connor OA. Umbralisib, a novel PI3Kdelta and casein kinase-1epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018 Apr;19(4):486-496. doi: 10.1016/S1470-2045(18)30082-2. Epub 2018 Feb 20. PMID 29475723