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

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono; Threshold Pharmaceuticals
• Collaborator: Threshold Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

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