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Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT02235701
Recruitment Status : Unknown
Verified October 2016 by CytRx.
Recruitment status was:  Recruiting
First Posted : September 10, 2014
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
CytRx

Brief Summary:
This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.

Condition or disease Intervention/treatment Phase
Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma Drug: aldoxorubicin Drug: ifosfamide Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1/2 Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aldoxorubicin Drug: aldoxorubicin
administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Other Name: INNO-206

Drug: aldoxorubicin
administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Other Name: INNO-206

Drug: aldoxorubicin
administered 350 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Other Name: INNO-206

Drug: ifosfamide



Primary Outcome Measures :
  1. Safety Measures [ Time Frame: 14 months ]
    The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.


Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: 17 months ]
    The secondary objective of this study is to evaluate the activity of aldoxorubicin in combination with ifosfamide/mesna in this population, assessed by overall response rate and progression-free survival (PFS).



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 15-80 years, male or female.
  2. 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.
  3. Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic soft tissue sarcoma (including rhabdomyosarcoma, Ewing's sarcoma and mixed mesodermal sarcoma), chondrosarcoma or osteosarcoma of intermediate or high grade and gastrointestinal stromal tumors (GIST) (only in subjects that have progressed after receiving treatment with imatinib and sunitinib).
  4. Capable of providing informed consent and complying with trial procedures.
  5. ECOG performance status 0-2.
  6. Life expectancy >12 weeks.
  7. Measurable tumor lesions according to RECIST 1.1 criteria.
  8. Women must not be able to become pregnant (eg 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.)
  9. Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment.
  10. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
  11. Geographic accessibility to the site that ensures the subject will be able to keep all study-related appointments.

Exclusion Criteria:

  1. Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence for at least 12 months.
  2. Prior exposure to >3 cycles or 225 mg/m2 of doxorubicin or Doxil®.
  3. Palliative surgery and/or radiation treatment less than 30 days prior to enrollment.
  4. Exposure to any investigational agent within 30 days of enrollment.
  5. Current Stage 1 or 2 soft tissue sarcomas.
  6. Current evidence/diagnosis of alveolar soft part sarcoma, dermatofibrosarcoma, Kaposi's sarcoma, clear cell sarcomas and unresectable low grade liposarcomas.
  7. Central nervous system metastasis if symptomatic.
  8. 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.
  9. 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, albumin <2 gm/dL, coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5 × ULN.
  10. Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235701


Locations
United States, California
Sarcoma Oncology Center Recruiting
Santa Monica, California, United States, 90403
Contact: Victoria Chua    310-552-9999    vchua@sarcomaoncology.com   
Principal Investigator: Sant Chawla, M.D.         
Sponsors and Collaborators
CytRx
Investigators
Study Director: Dan Levitt, M.D. CytRx Coporation

Responsible Party: CytRx
ClinicalTrials.gov Identifier: NCT02235701     History of Changes
Other Study ID Numbers: ALDOXORUBICIN-P1/2-STS-03
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by CytRx:
soft tissue sarcoma
aldoxorubicin
ifosfamide
mesna
phase 1
INNO-206

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Ifosfamide
Isophosphamide mustard
Doxorubicin
Mesna
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protective Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors