COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Phase II Trial of TPI 287 in Patients Advanced, Unresectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553813
Recruitment Status : Terminated (Insufficient funding)
First Posted : November 6, 2007
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):
Cortice Biosciences, Inc.

Brief Summary:
The primary objective of the study is to assess the activity of TPI 287 as single agent therapy for patients with advanced, unresectable pancreatic cancer after failure of gemcitabine-containing therapy. Activity of TPI 287 will be determined by the 6-month survival rate.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: TPI 287 Phase 2

Detailed Description:

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 infusion.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: TPI 287
    Intravenous dose of 125 mg/m2 TPI 287 on Day 1, Day 8, and Day 15 in a repeating 28 day cycle.

Primary Outcome Measures :
  1. Survival [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Ongoing ]
  2. Evaluate time to worsening of clinical status as measured by changes in pain, Karnofsky score, and weight. [ Time Frame: Ongoing ]
  3. Response rates and time to progression of tumor marker levels (CA 19-9) [ Time Frame: Ongoing ]
  4. Assess the safety and tolerability of TPI 287 in this patient population [ Time Frame: Ongoing ]
  5. Evaluate outcomes of patient subsets defined by duration of prior gemcitabine therapy [ Time Frame: Ongoing ]
  6. Evaluate the gene expression profile in relation to clinical outcomes [ Time Frame: Ongoing ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 metastases)
  • Patient must have recovered from prior surgery, radiotherapy or other antineoplastic therapy
  • 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 immunotherapy
  • 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 years
  • 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 indication)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553813

Layout table for location information
United States, California
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage,, California, United States, 92270
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University
Baltimore, Maryland, United States, 21231-1000
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Hospital Madrid
Madrid, Spain, 28250
Sponsors and Collaborators
Cortice Biosciences, Inc.
Layout table for investigator information
Study Director: Sandra Silberman, MD SLS Oncology, LLC
Additional Information:
Layout table for additonal information
Responsible Party: Cortice Biosciences, Inc. Identifier: NCT00553813    
Other Study ID Numbers: TPI 287-06
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Cortice Biosciences, Inc.:
TPI 287
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases