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Study of TPI 287 in Patients With Advanced Malignancies

This study has been completed.
Sponsor:
Information provided by:
Cortice Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00113724
First received: June 9, 2005
Last updated: June 3, 2009
Last verified: June 2009

June 9, 2005
June 3, 2009
May 2005
January 2008   (final data collection date for primary outcome measure)
To determine the maximum tolerated dose of TPI 287
Same as current
Complete list of historical versions of study NCT00113724 on ClinicalTrials.gov Archive Site
  • To determine the safety of TPI 287
  • To determine the antitumor activity of TPI 287
  • To determine the pharmacokinetic profile of TPI 287
  • To determine the pharmacodynamic profile of TPI 287
Same as current
Not Provided
Not Provided
 
Study of TPI 287 in Patients With Advanced Malignancies
A Phase I, Open-Label, Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies

Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, phase I study evaluating the intravenous administration of TPI 287, a novel third generation taxane.

The primary objective of this study is to determine the maximum tolerated dose of TPI 287 for phase II clinical trials.

The secondary objectives of the study are:

  • To determine the safety of TPI 287
  • To determine antitumor activity of TPI 287
  • To determine the pharmacokinetic profile of TPI 287
  • To determine the pharmacodynamic profile of TPI 287
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neoplasms
  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
Drug: TPI 287 Injection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological or cytological evidence of malignancy
  • Patients must have either:

    • advanced solid tumors that have recurred or progressed following standard therapy, or
    • Hodgkin's or non-Hodgkin's lymphoma that has recurred or progressed following standard therapy, have not had a previous bone marrow transplant, and are not eligible for a bone marrow transplant.
  • Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
  • Ambulatory with ECOG 0 or 1, and a life expectancy of >3 months.
  • Judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
  • Have ability to read, understand and provide written informed consent for the initiation of any study related procedures or have a legal representative to perform this function.
  • If female, must have a negative pregnancy test within 21 days of start of treatment.
  • Agree to the use of an effective method of contraception during the study and for 90 days following the last dose of medication.
  • Patients with prior radiation therapy for brain metastasis or primary brain tumors are acceptable.

Exclusion Criteria:

  • Prior radiation therapy or chemotherapy within 4 weeks (6 weeks for prior nitrosoureas or mitomycin)
  • Another active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome evaluation of the study drug. While this exclusion is not limited to the following abnormalities, if any of the following laboratory abnormalities are present, the patient should be excluded:

    • WBC < 3000/uL;
    • Absolute neutrophil count < 1500/uL;
    • Platelets < 100,000/uL;
    • Total bilirubin > 1.5 x upper limit of normal;
    • ALT or AST > 3 x upper limit of normal if no liver metastases or >5 upper limit of normal in the presence of liver metastases;
    • Serum creatinine > 1.5 x upper limit of normal;
    • INR >2.0.
  • Patient has clinically significant cardiac co-morbidities or pulmonary impairment
  • Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal and/or biological treatment for cancer including immunotherapy while on study. Of note, therapy with LHRH for prostate cancer is acceptable.
  • Patient has been treated with any investigational drug, investigational biologic, or investigational therapeutic device within 30 days of initiating study treatment.
  • Tumor appears to involve a major artery or vein.
  • Prior or concurrent significant CNS disease including stroke, except for primary or secondary malignancies.
  • Less than 4 weeks since prior major surgery
  • Known positive for HIV, Hepatitis B or C
  • Concurrent chronic use of aspirin (325 mg/day or more)
  • Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters) Of note, therapy with low-molecular weight heparin is acceptable as long as the INR<2.0.
  • Uncontrolled hypertension
  • Grade II-IV peripheral vascular disease within the past year
  • Prior allergic reactions to compounds of similar chemical or biologic composition to TPI 287, paclitaxel or taxotere, Cremophor-EL-P, or other study agents
  • Significant traumatic injury within the past 4 weeks
  • Ongoing or active infection requiring parenteral antibiotics or with a fever >38.1°C within 3 days of the first scheduled day of dosing
  • Other concurrent uncontrolled illness which may interfere with the ability of the patient to participate in the trial
  • Patients who are inpatients
  • Grade II-IV peripheral neuropathy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00113724
TPI 287-01
No
Tapestry Pharmaceuticals
Cortice Biosciences, Inc.
Not Provided
Study Director: Michael Kurman, MD Tapestry Pharmaceuticals, Inc.
Cortice Biosciences, Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP