Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00256191
Other study ID # TPI 287-02
Secondary ID
Status Completed
Phase Phase 1
First received November 16, 2005
Last updated October 11, 2007
Start date November 2005
Est. completion date February 2007

Study information

Verified date November 2005
Source Cortice Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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 1 study evaluating the intravenous administration of TPI 287 on an every 21 day cycle.


Description:

The primary objective of this study is to determine the maximum tolerated dose of TPI 287 administered every 21 days for Phase II clinical trials.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

Patients must be/have:

- Histological evidence of malignancy

- Advanced solid tumors that have recurred or progressed following standard therapy

- Failed one prior therapy or have no standard therapy available

- Ambulatory with ECOG of 0-1 and estimated life expectancy of > 3 months

- If female, negative pregnancy test

- If of childbearing years, agree to use birth control

- If patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month

Exclusion Criteria:

Patients will be excluded if they are or have had:

- Prior radiation within 4 weeks

- Active medical condition or organ disease which may compromise safety or interfere with the study

- Clinically significant cardiac co-morbidities or pulmonary impairment

- Concomitant therapy needs

- Treated with any investigational drugs within 30 days

- Tumors involve major artery or vein

- Prior or concurrent central nervous system (CNS) disease

- Less than 4 weeks since major surgery

- Known to be positive for HIV, hepatitis B or C

- Concurrent use of aspirin

- Use of thrombolytic agents

- Uncontrolled hypertension

- Grade II-IV peripheral vascular disease

- Pregnant or lactating

- Prior allergic history to compounds of similar chemical composition

- Inpatients

- Grade II-IV peripheral neuropathy

Study Design

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


Intervention

Drug:
TPI 287 Injection


Locations

Country Name City State
United States Rocky Mountain Cancer Center Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
Cortice Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the maximum tolerated dose of TPI 287 administered every 21 days
Secondary To determine the safety of TPI 287
Secondary To determine the antitumor activity of TPI 287
Secondary To determine the pharmacokinetic profile of TPI 287
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Not yet recruiting NCT02806557 - Profiling Neutrophil Counts in Patients on Chemotherapy N/A