Clinical trial · Interventional
TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors
NCT02574663CI-TRIAL-00040956completedPhase 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)
This is a Phase 1 multi-center study to assess the safety and efficacy of TGR-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with FOLFOX in patients with select relapsed or refractory solid tumors.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Stromal Tumor (GIST) | Gastrointestinal Stromal Tumor | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nab-paclitaxel + gemcitabine | Drug | — | UNRESOLVED |
| Oxaliplatin + Folinic acid + Fluorouracil | Drug | — | UNRESOLVED |
| Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab | Drug | — | UNRESOLVED |
| TGR-1202 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- TGR-1202
- description
- TGR-1202 daily dose
- interventionNames
- Drug: TGR-1202
- type
- EXPERIMENTAL
- label
- TGR-1202 + nab-paclitaxel + gemcitabine
- description
- TGR-1202 oral daily dose + nab-paclitaxel + gemcitabine both as an IV infusion
- interventionNames
- Drug: TGR-1202
- Drug: nab-paclitaxel + gemcitabine
- type
- EXPERIMENTAL
- label
- TGR-1202 + FOLFOX
- description
- TGR-1202 oral daily dose + oxaliplatin IV infusion + leucovorin IV infusion followed by 5-fluorouracil IV bolus followed by 5-FU IV infusion (FOLFOX regimen)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed: 1. adenocarcinoma of the pancreas (pancreatic cancer) 2. adenocarcinoma of the colon or rectum (colorectal cancer) 3. adenocarcinoma of the gastric (gastric cancer) 4. esophageal cancer 5. gastrointestinal stromal tumor (GIST) * Relapsed or refractory disease * Measurable lesion by RECIST 1.1 Exclusion Criteria: * Known Hepatitis B, C or HIV infection * Previous therapy with any drug that inhibits the PI3K pathway * Anti-tumor therapy within 21 days of study Day 1
References
Publications (0)
Data not yet available
No reference posted for this study.