Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01514188
Other study ID # INNO-206-P2-STS-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 11, 2012
Est. completion date December 15, 2014

Study information

Verified date September 2013
Source ImmunityBio, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

One hundred five subjects will be enrolled and randomized 2:1 to receive either INNO-206 or doxorubicin. INNO-206 at a dosage of 350 mg/m2 (doxorubicin equivalents of 260 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle to approximately 70 subjects. Doxorubicin (75 mg/m2) will be administered to approximately 35 subjects on Day 1 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is withdrawn from therapy or until a maximum of 6 cycles are administered. Overall response rates as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST 1.1.[28] Time-to-event endpoints, including PFS and OS will be assessed using the Kaplan Meier method.[30] Evaluation of 4- and 6-month progression-free survival will also be performed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 4.0 (published 28 May 2009).


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date December 15, 2014
Est. primary completion date April 9, 2014
Accepts healthy volunteers No
Gender All
Age group 15 Years to 80 Years
Eligibility 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. 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


Related Conditions & MeSH terms


Intervention

Drug:
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
Doxorubicin
Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.

Locations

Country Name City State
Australia Royal Hobart Hospital Hobart
Australia Mount Medical Centre Perth
Australia Royal Perth Hospital Perth
Australia Epworth HealthCare Clinical Trials and Research Centre Richmond Victoria
Australia Royal North Shore St. Leonards New South Wales
Australia The Crown Princess Mary Cancer Centre Westmead Sydney
Australia Border Medical Oncology Wodonga Victoria
Hungary State Health Centre Oncology Department Budapest
India Hemato Oncology Clinic, Vedanta Institute of Medical Science Ahmedabad Gujarat
India M.S. Ramaiah Medical College and Hospitals Bangalore Karnataka
India Noble Hospital Clinical Research Department 1st Floor Hadapsar Pune Maharashtra
India Delhi State Cancer Institute Mandoli Delhi
India Tata Memorial Hospital, Department of Medical Oncology Mumbai
India Curie Manavata Cancer Centre Nashik Maharashtra
India Delhi State Cancer Institute Pune Maharashtra
India Jehangir Clinical Development Centre Pvt Ltd Pune Maharashtra
India Hemato Oncology Clinic, Vedanta Institute of Medical Science Thaltej Ahmedaba
India Christian Medical College Vellore Tami Nadu
Romania Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie Baia-Mare Judet Maramures
Romania Medisprof SRL Cluj-Napoca
Romania Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca Cluj-Napoca County Cluj
Romania Clinical County Hospital Mures, Medical Oncology Department Targu-Mures County Mures
Russian Federation State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" Kazan Republic Of Tatarstan
Russian Federation Blokhin Cancer Research Center Moscow
Ukraine Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary", Chernivtsi
Ukraine Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel Dnipropetrovsk
Ukraine State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine", Kharkiv
Ukraine Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department Lviv
Ukraine Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department Vinnytsya
United States University of Iowa Iowa City Iowa
United States Pennsylvania Hematology Oncology Associates Philadelphia Pennsylvania
United States CTRC Institute for Drug Development, University of Texas San Antonio Texas
United States Sarcoma Oncology Center Santa Monica California
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
ImmunityBio, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Hungary,  India,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival Progression-free survival is defined as the interval from the date of registration (ie, assignment of subject number) to the earliest date of documented evidence of recurrent or progressive disease, or the date of death due to any cause, whichever occurs first.
Progressive Disease is defined as: 20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 new lesion is also considered progression.
Approximately 24 months
Secondary Overall Survival Overall survival was measured from the date of registration (ie, assignment of subject number) to the date of death due to any cause, or the date of last contact. Approximately 35 months
Secondary Progression-free Survival at 4 and 6 Months Month 4 and 6
Secondary Objective Overall Response Rate (ORR) Objective Overall Response will be evaluated using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). Changes (i.e., improvements) in tumor measurements from baseline values will be assigned a status of CR or PR. Objective response measurements will comprise the sum of CR plus PR.
Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm).
Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.
Approximately 24 months
Secondary Number of Participants With Treatment-related Toxicities (Adverse Events) Treatment will continue every 21 days until tumor progression is observed, 6 cycles of treatment are completed or unacceptable toxicity occurs. 30 days after last dose, up to 136 days (6 cycles of treatment plus 30 days)
See also
  Status Clinical Trial Phase
Terminated NCT03670069 - Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas Phase 1
Recruiting NCT05075993 - Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors Phase 1
Active, not recruiting NCT03793361 - Phase II Study of Regorafenib as Maintenance Therapy Phase 2
Completed NCT03009201 - Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery Phase 1
Withdrawn NCT03397186 - Immune Changes Following Trabectedin in Patients With Metastatic or Unresectable Sarcoma Phase 2
Recruiting NCT03965234 - Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases Phase 1/Phase 2
Recruiting NCT04028063 - Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas Phase 2
Active, not recruiting NCT04200443 - Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma Phase 2
Recruiting NCT05711615 - Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma Phase 1
Completed NCT01574716 - Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation Phase 2
Completed NCT02500797 - Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery Phase 2
Recruiting NCT03138161 - SAINT:Trabectedin, Ipilimumab and Nivolumab as First Line Treatment for Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Active, not recruiting NCT03660930 - Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas Phase 1/Phase 2

External Links