Clinical Trial testing TH-302 in combination with gemcitabine in combination in previously untreated patients with pancreatic cancer

Phase 1

• Conditions: ocally advanced unresectable pancreatic adenocarcinoma; MedDRA version: 19.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002957-42-FI
• Lead Sponsor: Threshold Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-26
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

- At least 18 years of age.
- Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by
histology or cytology and previously untreated with chemotherapy or systemic therapy
- Measurable disease (at least one target lesion outside of previous radiation fields) or
non-measurable disease by RECIST 1.1 criteria (see Appendix III).
- Documentation of disease progression since any prior therapy.
- Life expectancy of at least 3 months.
- Acceptable liver function.
- Acceptable renal function.
- Acceptable hematologic status.
- See protocol for fulll list of inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial
infarction within 6 months prior to the date of randomization, unstable arrhythmia or
symptomatic peripheral arterial vascular disease.
2. Symptomatic ischemic heart disease.
3. Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at
least 3 months).
4. Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately
treated non-melanoma skin cancer or pre-invasive cancer of the cervix.
5. Severe chronic obstructive or other pulmonary disease with hypoxemia
6. Major surgery, other than diagnostic surgery, =28 days prior to the date of randomization.
Subject must have completely recovered from surgery.
7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
8. Treatment of pancreatic cancer with radiation therapy or surgery =28 days prior to the date of
randomization.
9. Prior therapy with a hypoxic cytotoxin.
10. Subjects who participated in an investigational drug or device trial =28 days prior to Day 1 of
the first cycle.
11. Known infection with HIV, or an active infection with hepatitis B or hepatitis C.
12. Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or
the drug product excipients or to gemcitabine or its excipients.
13. See protocol for full list of exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified