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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01514188




Registration number
NCT01514188
Ethics application status
Date submitted
12/01/2012
Date registered
23/01/2012
Date last updated
29/05/2024

Titles & IDs
Public title
Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
Scientific title
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
Secondary ID [1] 0 0
INNO-206-P2-STS-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Soft Tissue Sarcoma 0 0
Locally Advanced Soft Tissue Sarcoma 0 0
Unresectable Soft Tissue Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INNO-206
Treatment: Drugs - Doxorubicin

Active comparator: Doxorubicin -

Experimental: INNO-206 -


Treatment: Drugs: INNO-206
INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles

Treatment: Drugs: Doxorubicin
Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Approximately 35 months
Secondary outcome [2] 0 0
Progression-free Survival at 4 and 6 Months
Timepoint [2] 0 0
Month 4 and 6
Secondary outcome [3] 0 0
Objective Overall Response Rate (ORR)
Timepoint [3] 0 0
Approximately 24 months
Secondary outcome [4] 0 0
Number of Participants With Treatment-related Toxicities (Adverse Events)
Timepoint [4] 0 0
30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)

Eligibility
Key inclusion criteria
* Age between 15-80 years (US only), and 18-80 (rest of world (ROW)), male or female.
* Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor recurrence for at least 12 months since the last measurement, beginning or end of last chemotherapy.
* Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic soft tissue sarcoma of intermediate or high grade.
* Capable of providing informed consent and complying with trial procedures.
* ECOG performance status 0-2.
* Life expectancy > 12 weeks.
* Measurable tumor lesions according to RECIST 1.1 criteria.
* Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
* Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
* Geographic accessibility to the site that ensures the subject will be able to keep all study-related appointments.
Minimum age
15 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence for at least 12 months.
* Prior exposure to > 3 cycles or 225 mg/m2 of doxorubicin or Doxil®.
* Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization.
* Exposure to any investigational agent within 30 days of Randomization.
* Current Stage 1 or 2 soft tissue sarcomas.
* Current evidence/diagnosis of alveolar soft part sarcoma, chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma, Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, clear cell sarcomas and unresectable low grade liposarcomas.
* Central nervous system metastasis
* History of other malignancies except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for > 5 years.
* Laboratory values: Screening serum creatinine > 1.5x upper limit of normal (ULN), alanine aminotransferase (ALT) > 3 × ULN or >5 × ULN if liver metastases are present, total bilirubin > 3 × ULN, absolute neutrophil count < 1,500/mm3, platelet concentration < 100,000/mm3, hematocrit level < 25% for females or < 27% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5 × ULN, albumin < 2.0 g/dL.
* Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.
* Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
* Baseline QTc > 470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
* History or signs of active coronary artery disease with or without angina pectoris.
* Serious myocardial dysfunction defined as scintigraphically (e.g. MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) < 45% of predicted.
* History of HIV infection.
* Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
* Major surgery within 3 weeks prior to Randomization.
* Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
* Any condition that is unstable and could jeopardize the subject's participation in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/12/2014
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore - St. Leonards
Recruitment hospital [2] 0 0
Epworth HealthCare Clinical Trials and Research Centre - Richmond
Recruitment hospital [3] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 0 0
Mount Medical Centre - Perth
Recruitment hospital [7] 0 0
The Crown Princess Mary Cancer Centre Westmead - Sydney
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
- Richmond
Recruitment postcode(s) [3] 0 0
3690 - Wodonga
Recruitment postcode(s) [4] 0 0
- Hobart
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Hungary
State/province [5] 0 0
Budapest
Country [6] 0 0
India
State/province [6] 0 0
Ahmedaba
Country [7] 0 0
India
State/province [7] 0 0
Delhi
Country [8] 0 0
India
State/province [8] 0 0
Gujarat
Country [9] 0 0
India
State/province [9] 0 0
Karnataka
Country [10] 0 0
India
State/province [10] 0 0
Maharashtra
Country [11] 0 0
India
State/province [11] 0 0
Pune Maharashtra
Country [12] 0 0
India
State/province [12] 0 0
Tami Nadu
Country [13] 0 0
India
State/province [13] 0 0
Mumbai
Country [14] 0 0
Romania
State/province [14] 0 0
County Cluj
Country [15] 0 0
Romania
State/province [15] 0 0
County Mures
Country [16] 0 0
Romania
State/province [16] 0 0
Judet Maramures
Country [17] 0 0
Romania
State/province [17] 0 0
Cluj-Napoca
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Republic Of Tatarstan
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Moscow
Country [20] 0 0
Ukraine
State/province [20] 0 0
Chernivtsi
Country [21] 0 0
Ukraine
State/province [21] 0 0
Dnipropetrovsk
Country [22] 0 0
Ukraine
State/province [22] 0 0
Kharkiv
Country [23] 0 0
Ukraine
State/province [23] 0 0
Lviv
Country [24] 0 0
Ukraine
State/province [24] 0 0
Vinnytsya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImmunityBio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01514188
Trial related presentations / publications
Chawla SP, Papai Z, Mukhametshina G, Sankhala K, Vasylyev L, Fedenko A, Khamly K, Ganjoo K, Nagarkar R, Wieland S, Levitt DJ. First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial. JAMA Oncol. 2015 Dec;1(9):1272-80. doi: 10.1001/jamaoncol.2015.3101.
Public notes

Contacts
Principal investigator
Name 0 0
Sant Chawla, M.D.
Address 0 0
Sarcoma Oncology Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01514188