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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

Phase 2
15 Years
80 Years
Open (Enrolling)
Metastatic Soft Tissue Sarcoma, Locally Advanced Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma

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Trial Information

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

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withdrawn from therapy or until a maximum of 6 cycles are administered.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).

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Progression-free survival (PFS) is defined as the time from enrollment to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.

Outcome Time Frame:

Over the duration of the trial, approximately 24 months

Safety Issue:


Principal Investigator

Sant Chawla, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarcoma Oncology Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

April 2014

Related Keywords:

  • Metastatic Soft Tissue Sarcoma
  • Locally Advanced Soft Tissue Sarcoma
  • Unresectable Soft Tissue Sarcoma
  • sarcoma
  • soft-tissue sarcoma
  • Metastatic,locally advanced, or unresectable soft tissue sarcoma
  • Sarcoma



University of Iowa Iowa City, Iowa  52242
Stanford University Stanford, California  94305
Sarcoma Oncology Center Santa Monica, California  90403
Pennsylvania Hematology Oncology Associates Philadelphia, Pennsylvania  19106
CTRC Institute for Drug Development, University of Texas San Antonio, Texas  78229-3900