Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

ImmunoGenesis

Status and phase

Terminated

Phase 1

Conditions

Pancreatic Cancer

Treatments

Drug: Nab-paclitaxel

Drug: TH-302

Drug: Gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02047500

EMR200592-006

Details and patient eligibility

About

This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects greater than or equal to (>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:
- Radiosensitizing doses of 5-fluorouracil;
- Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
- Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
- Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
Subjects may have measurable or non-measurable disease according to RECIST 1.1.
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Acceptable hematological status, liver and renal function as defined in the protocol
Other protocol defined inclusion criteria could apply

Exclusion criteria

Significant cardiac or peripheral vascular arterial disease
Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
Severe chronic obstructive or other pulmonary disease with hypoxemia
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Subjects receiving concomitant treatment with radiotherapy or other investigational drugs
Other protocol defined exclusion criteria could apply