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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01514188