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Anti-tumor antibiotic

INNO-206 for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Led By Sant Chawla, M.D.
Research Sponsored by CytRx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 4 and 6
Awards & highlights

Study Summary

This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.

Eligible Conditions
  • Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 4 and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 4 and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
Objective overall response rate (ORR)
Overall Survival
Progression-free survival at 4 and 6 months
+1 more

Side effects data

From 2015 Phase 2 trial • 32 Patients • NCT01205503
47%
Anemia
41%
Nausea
31%
Lymphocyte count decreased
28%
Fatigue
28%
White blood cell decreased
28%
Neutrophil count decreased
13%
Platelet count decreased
13%
Headache
13%
Hypoatremia
13%
Constipation
13%
Paresthesia
9%
Cough
9%
Alanine aminotransferase increased
9%
Hypocalcemia
9%
Hypokalemia
9%
Myalgia
9%
Vomiting
9%
Hypoalbuminemia
6%
Dyspnea
6%
Febrile neutropenia
6%
Hypernatremia
6%
Edema Limbs
6%
Mucositis oral
6%
Pain
6%
Chills
6%
Flank Pain
6%
Insomnia
3%
Hemorrhoids
3%
Vaginal Infection
3%
MRSA positive infection in toe
3%
Urinary Frequency
3%
Rash maculo-papular
3%
Diarrhea
3%
Depression
3%
Fibrinogen decreased
3%
Gastritis
3%
Hypomagnesemia
3%
Hypotension
3%
Non-cardiac chest pain
3%
Pain in extremity
3%
Palpitations
3%
Pruritus
3%
Sore Throat
3%
Wheezing
3%
Blurred Vision
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Allergic rhinitis
3%
Anorexia
3%
Lung Infection
3%
Arthralgia
3%
Dermatitis
3%
Creatinine increased
3%
Esophageal Spasms
3%
Hyperglycemia
3%
Lip Infection
3%
Muscle weakness upper limb
100%
80%
60%
40%
20%
0%
Study treatment Arm
Saline
Mesna

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: INNO-206Experimental Treatment1 Intervention
Group II: DoxorubicinActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldoxorubicin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

CytRxLead Sponsor
21 Previous Clinical Trials
1,462 Total Patients Enrolled
Sant Chawla, M.D.Principal InvestigatorSarcoma Oncology Center
1 Previous Clinical Trials
24 Total Patients Enrolled
Daniel Levitt, M.D., Ph.D.Study DirectorCytRx
3 Previous Clinical Trials
57 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
2011. "Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01514188.
All > Soft Tissue Sarcoma
~8 spots leftby Apr 2025
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