Intravenously Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PROMITIL) in Cancer Patients With Solid Tumors.

Sponsor
Lipomedix Pharmaceuticals Inc.
Study ID
NCT01705002
Phase
PHASE1
Status
Completed

Conditions

  • Cancer
  • Metastatic Colorectal Cancer (mCRC)
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Promitil — DRUG
    2 mg/kg dose IV
  • Capecitabine — DRUG
    1000 mg dose BID PO for days 1-21 for Combination Cohort and on day 1-14 on Triple combination Cohort
  • Bevacizumab — DRUG
    for Triple combination cohort an IV dose of 5 mg/kg on day 1 at 4 week interval. For the 3 weekly cohort an IV dose of 7.5 mg/kg at 3 week interval.

Study Details

This is a Phase I, multi-center, Dose-Escalating, Safety Study of an Intravenously Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PL-MLP, PROMITIL) in Cancer Patients with Solid Tumors. The study comprised of: Escalated cohorts A-H: 27 male or female participants, ages 18-80, BMI 18-36 diagnosed with inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have failed to respond to standard therapy or for whom no standard therapy is available. Eligible subjects will be assigned, successively in order of accrual, to one of eight cohorts, to receive escalating doses of intravenously infused PROMITIL. PROMITIL will be administered as an intravenous infusion. Dose escalation will only proceed in the absence of dose-limiting toxicity (DLT). For this purpose, each cohort will only begin its first cycle of PROMITIL when the cohort preceding it has successfully completed its first 4-week cycle without any signs of DLT. Expanded cohort: 17 adult patients with metastatic CRC. The purpose of this expanded cohort is to further evaluate the safety of Promitil and to search for signs of antitumor activity of Promitil in this specific patient population. Combination Cohort (Promitil concomitantly with Capecitabine): 23 adult patients with metastatic CRC. Triple combination Cohort: 13 additional subjects with metastatic CRC, received combination of Promitil concomitantly with Bevacizumab (5 mg/kg) on day 1 of a 28 day cycle and Capecitabine on days 1-14 of a 28 day cycle. 3 weekly cohort- 9 subjects with metastatic CRC will receive Promitil and Bevacizumab (7.5 mg/kg) on day 1 of a 21 day cycle.

Key Dates

First listed
Oct 12, 2012
Start date
Oct 31, 2012
Status verified
Jul 2018
Primary completion
Nov 30, 2017
Completion
Jun 30, 2018

Study Design

Enrollment
88 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Promitil 0.5 mg/kg
    Three treatment cycles, intravenous infusion of Promitil
  • Experimental: Cohort B: Promitil 1.0 mg/kg
    Three treatment cycles, intravenous infusion of Promitil
  • Experimental: Cohort C: Promitil 1.5 mg/kg
    Three treatment cycles, intravenous infusion of Promitil
  • Experimental: Cohort D: Promitil 2.0 mg/kg
    Three treatment cycles, intravenous infusion of Promitil
  • Experimental: Cohort E: Promitil 2.5 mg/kg
    Three treatment cycles, intravenous infusion of Promitil
  • Experimental: Cohort F: Promitil 3.0 mg/kg
    Three treatment cycles, intravenous infusion of Promitil
  • Experimental: Cohort G: Promitil 3.5 mg/kg
    Three treatment cycles, intravenous infusion of Promitil
  • Experimental: Cohort H: Promitil 4.0 mg/kg
    Three treatment cycles, intravenous infusion of Promitil
  • Experimental: Expanded Cohort
    Patients treated with the selected RP2D of PROMITIL (3 mg/kg) intravenously administered on their first cycle and reduced dose of 2 mg/kg from cycle 2 and onwards. Only for mCRC patients.
  • Experimental: Combination Cohort
    Patients treated with one cycle of 2.5mg/kg Promitil day 1 together with Capecitabine 1,000 mg bid po days 1-21 followed by two cycles of 2.0 mg/kg Promitil day 1 together with Capecitabine 1,000 mg bid po days 1-21, at four-week intervals. Only for mCRC patients.
  • Experimental: Triple combination Cohort
    Patients treated with one cycle of 2mg/kg Promitil I.v and 5 mg/kg Bevacizumab i.v on day 1 together with Capecitabine 1,000 mg bid p.o days 1-14 at four-week intervals. Only for mCRC patients.
  • Experimental: 3 Weekly Cohort
    Patients treated with one cycle of 2mg/kg Promitil I.v and 7.5 mg/kg Bevacizumab i.v on day 1 together at three-week intervals. Only for mCRC patients.

Primary Outcome Measure

Maximal Tolerated Dose (MTD) of PROMITIL [ Time Frame: First cycle of treatment (4 weeks) ]

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