TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors



Status:Active, not recruiting
Conditions:Colorectal Cancer, Colorectal Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:October 2015
End Date:December 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

TGR-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with
FOLFOX in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum,
gastric and GE junction cancer, and GI Stromal Tumor (GIST) who have relapsed from or are
refractory to prior treatment.

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
We found this trial at
1
site
TG Therapeutics Trial Site
Nashville, Tennessee 37203
Phone: 615-329-7247
?
mi
from
Nashville, TN
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