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A Phase I, Open-Label, Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies

Phase 1
18 Years
Not Enrolling
Neoplasms, Non-Hodgkin Lymphoma, Hodgkin Disease

Thank you

Trial Information

A Phase I, Open-Label, Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies

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

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

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose of TPI 287

Principal Investigator

Michael Kurman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Tapestry Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:

TPI 287-01



Start Date:

May 2005

Completion Date:

January 2008

Related Keywords:

  • Neoplasms
  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • taxane
  • multi-drug resistance
  • mutant tubulin binding
  • Advanced malignancies
  • Hodgkin's or Non-Hodgkin's Lymphoma
  • Neoplasms
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin



New York Medical College Valhalla, New York  10595
Rocky Mountain Cancer Center Denver, Colorado  80218
Arizona Clinical Research Center Tucson, Arizona  85712
Georgetown University Medical Center/Lombardi Cancer Center Washington, District of Columbia  20007