NCT02047500TerminatedPhase 1
An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- ImmunoGenesis
- Enrollment
- 19
- Locations
- 5
- Primary Endpoint
- Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Arms & Interventions
TH-302 plus Nab-paclitaxel plus Gemcitabine
Experimental
Intervention: TH-302 (Drug)
TH-302 plus Nab-paclitaxel plus Gemcitabine
Experimental
Intervention: Nab-paclitaxel (Drug)
TH-302 plus Nab-paclitaxel plus Gemcitabine
Experimental
Intervention: Gemcitabine (Drug)
Outcomes
Primary Outcomes
Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
Time Frame: Up to Day 28 of Cycle 1
Secondary Outcomes
- Percentage of Subjects With Disease Control According to RECIST Version 1.1 Criteria(Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment)
- Tumor Metabolic Response Assessed by Positron Emission Tomography (PET) Scans According to European Organization for Research and Treatment of Cancer (EORTC) Criteria(Baseline and 8 weeks after Day 1 of Cycle 1)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)(Baseline up to Day 30 after the last dose of study treatment)
- Duration of Overall Response According to RECIST Version 1.1 Criteria(Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment)
- Progression Free Survival (PFS) Time(Time from enrollment to progressive disease (PD) or occurrence of death due to any cause within 120 days of either first administration of study drug or the last tumor assessment)
- Percentage of Subjects With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) Criteria(Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment)
Investigators
Study Sites (5)
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