NCT00608803

CompletedPhase 1

Phase 1 Study of ZIO-201-T in Combination With Doxorubicin i...

Alaunos Therapeutics Source

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Other study identifiers

Sponsor study identifier

IPM1002

Study Type

interventional

Estimated enrollment

30

Locations

1 country

Sites

2

Timeline

Study Start

January 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2009

Actual (reported)

Study Completion

January 2009

Actual (reported)

Brief Summary

The study of safety of ZIO-201-T in combination with doxorubicin in the treatment of advanced cancer.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 30 participants
Study completion date: January 2009
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 22, 2008
Actual (reported)
First Posted
February 6, 2008
Actual (reported)
Primary Completion
January 2009
Actual (reported)
Study Completion
January 2009
Actual (reported)

Last Updated: September 17, 2009
Status Verified: September 2009
Last Update Submitted: September 16, 2009

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

Toxicities
5 months

Secondary Outcomes (1)

Pharmacokinetics
5 months

Study Arms (1)

Single arm

EXPERIMENTAL

Once the maximum tolerated dose (MTD) is determined, an expanded cohort of 20 subjects with advanced, ifosfamide and doxorubicin naive soft-tissue sarcoma subjects will be dosed at the MTD and evaluated for efficacy.

Drug: ZIO-201-T and doxorubicin

Interventions

ZIO-201-T and doxorubicinDrug

ZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm.

Single arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥18 years
Histological or cytological documentation of cancer

Sponsors & Collaborators

Alaunos Therapeutics
Industrylead

Study Sites (2)

Santa Monica, California, 90403, United States

Houston, Texas, 77024, United States

MeSH Terms

Interventions

Doxorubicin

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

Jonathan Lewis, MD, PhD
ZIOPHARM Oncology, Inc.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 6, 2008

Study Start

January 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2009

Actual (reported)

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Phase 1Completed

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Phase 1 Study of MKC-1 in Patients With Advanced Cancer

Phase 1Completed

NCT00607711

Study of Oral Palifosfamide Tris in Solid Tumors

Phase 1Withdrawn

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Bevacizumab and Temsirolimus in Patients With Advanced Malignancy

Phase 1Completed

NCT01524224

A Dose-Escalation Study in Participants With Advanced Cancer

Phase 1Completed

Measurable disease

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Ifosfamide and doxorubicin naïve

Life expectancy of at least 12 weeks

Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 7 days prior to dosing:Hemoglobin \>9.0 g/dL, Absolute neutrophil count (ANC) \>1,500/mm3,Platelet count ≥100,000/mm3,Total bilirubin \<1.5×ULN,ALT and AST ≤2.5×ULN,Partial thromboplastin \[PT\]-INR/activated partial thromboplastin time \[PTT\] \<1.5×ULN. Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate. Serum creatinine ≤ULN

Written, informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures

Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial.

Women of childbearing potential must have a pregnancy test performed within 7 days of the start of treatment.

You may not qualify if:

Clinically evident congestive heart failure \>Class II of the New York Heart Association (NYHA) guidelines
Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V
History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
History of HIV infection
Prior nephrectomy of history of urinary tract obstruction
Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy
Any major surgery within 3 weeks prior to start of treatment
Metastatic brain or meningeal tumors, unless the subject is \>6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).
Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis, \& T1\] or other malignancies curatively treated \>3 years prior to entry)
Pregnancy or lactation
Substance abuse or medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements

Contact the study team to confirm eligibility.

Study Completion

January 2009

Actual (reported)

Last Updated

September 17, 2009

Record last verified: 2009-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00608803
Data provider: ClinicalTrials.gov
Source updated: 2009-09-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:03 UTC

Locations

US(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Single arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations