Pancreatic Cancer
Conditions
Keywords
Pancreas, Cancer, Pancreatic Adenocarcinoma, Metastatic, Glufosfamide
Brief summary
The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.
Detailed description
TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells. Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care. Comparison: Glufosfamide versus best supportive care.
Interventions
DRUGGlufosfamide
Sponsors
PPD Development, LP
Threshold Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided) * Metastatic pancreatic cancer * Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer * Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion) * Recovered from reversible toxicities of prior therapy * Karnofsky performance status ≥70 * All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose * Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
Exclusion criteria
* More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen) * Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start * Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects) * Active clinically significant infection requiring antibiotics * Known HIV positive or active hepatitis B or C * Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure * No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year * Major surgery within 3 weeks of the start of study treatment, without complete recovery * Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin \<9 g/dL (may receive transfusion or erythropoietin to maintain))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of objective tumor response rate | — |
| Progression-free survival | — |
| 6 month and 12 month survival | — |
| Objective tumor response rate | — |
| Pain Intensity | — |
| Performance Status | — |
| Serum CA 19-9 | — |
Countries
Argentina, Brazil, Bulgaria, Czechia, Hungary, India, Mexico, Romania, Russia, Ukraine, United States
Outcome results
None listed