A Phase II Trial Of TPI 287 In Patients Advanced, Unresectable Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: TPI 287

TPI 287-06

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-11-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-01-09
First Submitted that Met QC Criteria 2007-11-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-01-22
First Posted (ESTIMATED) 2007-11-06	Results First Posted N/A	Last Verified 2014-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Survival		6 Months

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Sandra Silberman, MD, SLS Oncology, LLC

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record