Completed

A Phase I Trial of STA-4783 in Patients Receiving Paclitaxel for Treatment of Solid Tumors

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What is being tested

Data Collection

Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2003
See protocol details

Summary

Principal SponsorSynta Pharmaceuticals Corp.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2003Actual date on which the first participant was enrolled.

The purpose of this study is to determine the safety, toxicity and maximum tolerated dose of single doses of STA-4783/paclitaxel in combination when administered intravenously to patients with refractory cancer. To determine the pharmacokinetics of STA-4783 and paclitaxel when co-administered. To assess the anti-tumor activity of STA-4783 and paclitaxel when co-administered.

Official TitleA Phase I Trial of STA-4783 in Patients Receiving Paclitaxel for Treatment of Solid Tumors 
Principal SponsorSynta Pharmaceuticals Corp.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

Inclusion Criteria: * Male and female patients greater than or equal to 18 years of age with histologically confirmed malignancy that is metastatic or unresectable and for which no standard therapy exists. * Patients must not have received prior chemotherapy or radiation for greater than or equal to 4 weeks before study enrollment. * Patients may be entered if they have received prior radiation therapy involving less than or equal to 30% of the bone marrow. Any prior radiation therapy must have been administered greater than or equal to 4 weeks before study enrollment and the patient must be recovered from the acute toxic effects of the treatment prior to study entry. * Patients may be enrolled with a history of treated brain metastases that are clinically stable for greater than or equal to 4 weeks prior to enrollment. * ECOG Performance Status of less than or equal to 2. * Life expectancy of greater than 12 weeks. * No peripheral neuropathy \> grade 1 on NCI CTC version 2 scale, no history of stroke or other significant neurological limitations as determined by the investigator. * Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below. * Absolute neutrophil count greater than or equal to 1,500/ul * Platelets greater than or equal to 100,000 cells/ul * Total bilirubin must be within normal limits * AST(SGOT) less than or equal to 2.5 times the upper limit of normal * Serum creatinine \< 1.5 mg/dl or a measured creatine clearance greater than or equal to 50 mL/min * Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by investigator. * The effects of STA-4783 on the developing human fetus are unknown, however taxanes are known to be teratogenic. Therefore, women of childbearing potential (defined as women less than or equal to 50 years of age or history of amenorrhea for \< 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Women who are pregnant or lactating. * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients with previous high dose chemotherapy with autologous stem cell rescue bone marrow transplantation. * Use of any investigational agents within 4 weeks of study enrollment. * History of severe allergic reactions to paclitaxel or docetaxel including severe hypersensitivity reactions defined as greater than or equal to 3 based on NCI CTC version 2. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Beth Israel-Deaconess Medical CenterBoston, United StatesSee the location
Suspended
Dana Farber Cancer InstituteBoston, United States

Completed2 Study Centers
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