Know Cancer

forgot password

A Phase 2, Open Label, Single Arm Trial of TPI 287 in Patients With Advanced, Unresectable Pancreatic Cancer After Prior Treatment With a Gemcitabine-based Therapy

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

A Phase 2, Open Label, Single Arm Trial of TPI 287 in Patients With Advanced, Unresectable Pancreatic Cancer After Prior Treatment With a Gemcitabine-based Therapy

This is a multicenter, open-label, single arm Phase 2 study in patients with advanced,
unresectable pancreatic cancer who have received prior gemcitabine-based chemotherapy for
their disease. Patients will receive TPI 287 administered as a 60-minute (± 10 min) IV

The primary endpoint of the trial will be the 6-month survival rate. Additional efficacy
endpoints will be response rate, duration of response and stable disease, and 6-month
progression free survival. Responses will be assessed by reduction in radiographically
measurable disease as defined by the RECIST criteria. Time to worsening of clinical status
will be based on reductions in pain and/or analgesic use and changes in tumor markers (CA
19-9) will also be followed.

Patients will remain on study until tumor progression or death, unacceptable toxicity,
withdrawal of consent or discontinuation based on Investigator discretion. Patients will be
followed for survival for up to 1 year after enrollment on the study.

Inclusion Criteria:

- Patients must have histological or cytological confirmation of ductal adenocarcinoma
or undifferentiated carcinoma of the pancreas

- Patients must have metastatic disease precluding curative surgery

- Patients must have received only one prior systemic anticancer treatment for their
advanced disease, which must have included a gemcitabine-based therapeutic regimen
for advanced disease

- Patients may have received prior adjuvant therapy for their disease

- Patients must have a Karnofsky performance status ≥ 70 (Appendix I)

- Patients must be ≥ 18 years of age

- Women of childbearing potential (WOCBP):

- Must be using an adequate method of contraception to avoid pregnancy throughout
the study and for up to 4 weeks after the study

- Must have a negative serum or urine pregnancy test

- Patients must have adequate organ function:

- Bone marrow reserve as evidenced by: Absolute neutrophil count ≥1,500/uL,
Platelet count ≥ 100,000/uL

- Renal function as evidenced by serum creatinine ≥ 2.0 mg/uL

- Hepatic function as evidenced by: Serum total bilirubin < 2.0 mg/uL, SGOT/SGPT <
3X ULN for the reference lab (< 5X ULN for patients with known hepatic

- Patient must have recovered from prior surgery, radiotherapy or other antineoplastic

- Patients or their legal representative must be able to read, understand, and sign the
informed consent to participate in the trial

Exclusion Criteria:

- Patients with islet cell tumors, lymphoma, or sarcoma of the pancreas

- Patients with more than one prior treatment for metastatic pancreatic carcinoma

- Patients with current peripheral neuropathy > Grade 1

- Patients receiving any concurrent chemotherapy, radiotherapy, hormonal therapy or

- Patients with serious infection or a life-threatening illness (unrelated to tumor)
that is > Grade 2 NCI CTCAE V 3.0), or active, serious infections requiring parental
antibiotic therapy within 4 weeks prior to screening

- History of cardiac disease or events according to the New York Health Association
(NYHA) assessments. Clinically evident congestive heart failure as defined by NYHA
Class 3 or 4 CHF or cardiac arrhythmia, including atrial fibrillation, if not
adequately controlled

- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interferes with the
interpretation of the results

- Known HIV or Hepatitis B or C (active, previously treated or both)

- A history of other malignancy (except nonmelanoma skin cancer or carcinoma-in-situ of
cervix), unless in CR and not receiving therapy for that disease for a minimum of 5

- Patients with known hypersensitivity to any of the components of the drugs to be
administered on study

- Patients receiving concurrent investigational therapy (investigational therapy is
defined as treatment for which there is currently no regulatory authority-approved

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

6 Months

Safety Issue:


Principal Investigator

Sandra Silberman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Archer Biosciences


United States: Food and Drug Administration

Study ID:

TPI 287-06



Start Date:

October 2007

Completion Date:

April 2010

Related Keywords:

  • Pancreatic Cancer
  • Unresectable
  • Gemcitabine
  • Taxane
  • TPI 287
  • Pancreatic Neoplasms



Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Desert Hematology Oncology Medical Group, Inc. Rancho Mirage, California  92270
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University Baltimore, Maryland  21231-1000