Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer (NCT02047500) | Clinical Trial Compass
TerminatedPhase 1
Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer
Stopped: The trial has been terminated earlier following the company decision to discontinue the clinical development of Evofosfamide
United States19 participantsStarted 2014-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Subjects Experiencing Dose Limiting Toxicity (DLT)