Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytRx
ClinicalTrials.gov Identifier:
NCT01337505
First received: April 14, 2011
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.


Condition Intervention Phase
Malignant Solid Tumour
Drug: INNO-206
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1 Study to Investigate the Safety and Maximum Tolerated Dose of INNO-206 (Doxorubicin-6-Maleimidocaproyl Hydrazone; DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by CytRx:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 6 cycles (every 21 days) ] [ Designated as safety issue: Yes ]
    Safety will be based on adverse events, tolerability, physical examinations, vital signs, ECG results, laboratory test results. MTD: If 2 of 5 subjects an any dose level experiences a grade 3 or 4 non-hematologic toxicity, or a platelet count <25,000/uL or a neutrophil count <500/uL lasting >7 days and/or associated with fever >38.5C, 3 more subjects will be entered at that dose level. If 2 of 3 of the additional subjects experience any of the above adverse events, the dose level immediately below will be identified as the MTD.


Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Up to 6 cycles (every 21 days) ] [ Designated as safety issue: No ]
    To evaluate the objective response reate (OR; RECIST 1.1 criteria). Changes in tumor measurements from baseline values that are confirmed by repeat assessments will be assigned a status of CR or PR. OR=CR+PR.


Enrollment: 24
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INNO-206
INNO-206 at dosages of 230, 350, and 450 mg/m2 doxorubicin equivalents of 165, 260, and 325 mg/m2)will be administered as a 30 minute IVI on Day 1 of each cycle.
Drug: INNO-206
INNO-206 at dosages of 230, 350, and 450 mg/m2 (doxorubicin equivalents of 165, 260, and 325 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle.
Other Name: DOXO-EMCH

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 70 years, male or female.
  • Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy.
  • Subjects who have received prior radiation therapy with stable CNS metastasis with no progression of brain metastasis by CT/MRI scan in last 4 weeks.
  • Capable of providing informed consent and complying with trial procedures.
  • ECOG performance status 0-2.
  • Life expectancy >12 weeks.
  • Measurable or evaluable disease 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.
  • 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.

Exclusion Criteria:

  • Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks prior to the Screening Visit.
  • Exposure to any investigational agent within 30 days of the Screening Visit.
  • Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count < 3500/mm3, absolute neutrophil count < 2000/mm3, platelet concentration < 100,000/mm3, hematocrit level < 33% for females or < 35% for males, or coagulation tests (PT,PTT) >1.5 times the upper limit or normal.
  • Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.
  • Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
  • History or signs of active coronary artery disease with or without angina pectoris.
  • Serious myocardial dysfunction defined scintigraphically (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, antivirals or antifungals.
  • Major surgery within 3 weeks prior to treatment.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337505

Locations
United States, California
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Sponsors and Collaborators
CytRx
Investigators
Principal Investigator: Sant Chawla, M.D. Sarcoma Oncology Center
  More Information

No publications provided

Responsible Party: CytRx
ClinicalTrials.gov Identifier: NCT01337505     History of Changes
Other Study ID Numbers: INNO-206-P1-MTD-01
Study First Received: April 14, 2011
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CytRx:
INNO-206
Phase 1
DOXO-EMCH
Advanced solid tumors

Additional relevant MeSH terms:
Neoplasms
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014