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Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors

Primary Purpose

Solid Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sterile Compound C31510 for Injection
Sponsored by
Berg, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject has a histologically confirmed solid tumor that is metastatic or unresectable for which standard curative measures do not exist or are no longer effective.
  • The subject is at least 18 years old.
  • The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
  • The subject has a life expectancy of greater than 3 months.
  • The subject has organ and marrow function as follows: ANC>1500mm3, platelets>100,000 dl, hemoglobin >9 g/dL, bilirubin ≤ 1.5mg/dL, serum creatinine ≤1.5mg/dL or creatinine clearance >60 mL/min, and alanine aminotransferase (ALT), aspartate transaminase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement.
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
  • Sexually active subjects must use an accepted method of contraception during the course of the study.
  • Female patients of childbearing potential must have a negative pregnancy test at enrollment.
  • If a subject has received more than three prior regimens of cytotoxic chemotherapy, or more than two biological regimens, or more than 3000cGy to areas containing substantial marrow, the cohort review committee (CRC) must determine subject suitability prior to enrollment.

Exclusion Criteria:

  • The subject has received chemotherapy or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to entering the study.
  • The subject has received anti-angiogenesis drugs within 4 weeks prior to entering the study.
  • The subject has received radiation to ≥25% of his or her bone marrow within 4 weeks of C31510IV treatment.
  • The subject has received an investigational drug within 30 days of the first dose of study drug. 6 of 72
  • The subject has not recovered to grade ≤1 from adverse events( AEs) due to investigational drugs or other medications, which were administered more than 4 weeks prior to study enrollment.
  • The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • The subject is pregnant or lactating.
  • The subject is known to be positive for the human immunodeficiency virus (HIV)
  • The subject has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.
  • Must have not taken Vitamin D3 supplements in the last 30 days
  • The subject is on HMG-CoA Reductase Inhibitors
  • The subject is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids
  • The subject is receiving Colony Stimulating factors. The use of Colony Stimulating factors isf prohibited during the monitoring of DLT in this study.
  • The subject is receiving Warfarin.

Sites / Locations

  • Sarcoma Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Cohort 8

Cohort 9

Arm Description

5.62 mg/kg Sterile Compound C31510 for Injection

11.25 mg/kg Sterile Compound C31510 for Injection

22.5 mg/kg Sterile Compound C31510 for Injection

33.0 mg/kg

44.0 mg/kg Sterile Compound C31510 for Injection

58.7 mg/kg Sterile Compound C31510 for Injection

78.2 mg/kg Sterile Compound C31510 for Injection

104.3 mg/kg Sterile Compound C31510 for Injection

139.0 mg/kg Sterile Compound C31510 for Injection

Outcomes

Primary Outcome Measures

Tumor Assessment
Tumors will be assessed by standard methods ex. computerized tomography (CT), MRI etc; at baseline and then once every two treatment cycles of 28 days (2 months) thereafter in the absence of clinical rapid progression of disease. Assessment of tumor vascularity (using DCE-MRI) for at least 6 subjects who received C31510 at the MTD, will be done within 24 hours pre-dose and post-dose.

Secondary Outcome Measures

blood samples taken for plasma pharmacokinetics (PK) evaluation
samples are taken to evaluate plasma pharmacokinetics (PK) and estimate renal elimination of C31510 administered as a single IV infusion in subjects with solid tumors PK will be collected during Day 1 of the first month of each cohort at the following timepoints: pre-dose, post-start of infusion at 0.5, 1, 2, 3.75 (15 min prior to end of infusion), 4.083 (5 min after end of the infusion) 4.5, 6, 8, 10, and 24 hrs. after start of the infusion Additional PK will be done at pre-dose time and at 24 hours post the dose of Day 3, and on Day 28.
blood samples taken for plasma pharmacodynamics evaluation
blood samples are taken to evaluate the pharmacodynamic correlation of C31510 activity in plasma and peripheral blood cells

Full Information

First Posted
November 30, 2010
Last Updated
July 19, 2019
Sponsor
Berg, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01251562
Brief Title
Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors
Official Title
A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile Compound c31510 for Injection Administered Intravenously to Subjects With Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Berg, LLC

4. Oversight

5. Study Description

Brief Summary
The primary objective of this clinical study is as follows: • To determine the MTD and to assess the safety and tolerability of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors The secondary objective of this study is as follows: • To evaluate plasma PK and estimate renal elimination of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors The exploratory objectives of this study are as follows: To evaluate the pharmacodynamic correlates of C31510 activity in plasma and peripheral blood cells To radiographically evaluate the effects of C31510 on tumors. In selected subjects, the effects on vascular permeability will be assessed by digital contrast enhanced (DCE)-magnetic resonance imaging (MRI) To evaluate tumor response (preliminary antitumor activity) after repeat administration of C31510 Long-term safety and tolerability of C31510 after repeat administration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
5.62 mg/kg Sterile Compound C31510 for Injection
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
11.25 mg/kg Sterile Compound C31510 for Injection
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
22.5 mg/kg Sterile Compound C31510 for Injection
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
33.0 mg/kg
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
44.0 mg/kg Sterile Compound C31510 for Injection
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
58.7 mg/kg Sterile Compound C31510 for Injection
Arm Title
Cohort 7
Arm Type
Experimental
Arm Description
78.2 mg/kg Sterile Compound C31510 for Injection
Arm Title
Cohort 8
Arm Type
Experimental
Arm Description
104.3 mg/kg Sterile Compound C31510 for Injection
Arm Title
Cohort 9
Arm Type
Experimental
Arm Description
139.0 mg/kg Sterile Compound C31510 for Injection
Intervention Type
Drug
Intervention Name(s)
Sterile Compound C31510 for Injection
Intervention Description
During the treatment period, subjects in each initial dose level cohort will have a single 4-hour IV infusion of C31510 at the assigned dose level of their particular cohort, three times per week for 26 days (on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26) followed by a 28-day follow up period that will be counted from the first dose given on Day 1. In the absence of unacceptable toxicity or disease progression during the treatment period, those subjects may receive similar 28-day repeat treatment cycles of 3 times per week for up to 1 year, at the discretion of the investigator.
Primary Outcome Measure Information:
Title
Tumor Assessment
Description
Tumors will be assessed by standard methods ex. computerized tomography (CT), MRI etc; at baseline and then once every two treatment cycles of 28 days (2 months) thereafter in the absence of clinical rapid progression of disease. Assessment of tumor vascularity (using DCE-MRI) for at least 6 subjects who received C31510 at the MTD, will be done within 24 hours pre-dose and post-dose.
Time Frame
at baseline and then once every two treatment cycles of 28 days (2 months) thereafter in the absence of clinical rapid progression of disease.
Secondary Outcome Measure Information:
Title
blood samples taken for plasma pharmacokinetics (PK) evaluation
Description
samples are taken to evaluate plasma pharmacokinetics (PK) and estimate renal elimination of C31510 administered as a single IV infusion in subjects with solid tumors PK will be collected during Day 1 of the first month of each cohort at the following timepoints: pre-dose, post-start of infusion at 0.5, 1, 2, 3.75 (15 min prior to end of infusion), 4.083 (5 min after end of the infusion) 4.5, 6, 8, 10, and 24 hrs. after start of the infusion Additional PK will be done at pre-dose time and at 24 hours post the dose of Day 3, and on Day 28.
Time Frame
Blood samples collected at pre-dose, post-start of infusion at 0.5, 1, 2, 3.75 (15 min prior to end of infusion), 4.083 (5 min after the end of the infusion) 4.5, 6, 8, 10, and 24 hrs. after the start of the infusion
Title
blood samples taken for plasma pharmacodynamics evaluation
Description
blood samples are taken to evaluate the pharmacodynamic correlation of C31510 activity in plasma and peripheral blood cells
Time Frame
Pharmacodynamic blood samples will be collected pre-dose and at 4 and 24 hours post dose after start of the infusion of Day 1 of each treatment cycle.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject has a histologically confirmed solid tumor that is metastatic or unresectable for which standard curative measures do not exist or are no longer effective. The subject is at least 18 years old. The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2. The subject has a life expectancy of greater than 3 months. The subject has organ and marrow function as follows: ANC>1500mm3, platelets>100,000 dl, hemoglobin >9 g/dL, bilirubin ≤ 1.5mg/dL, serum creatinine ≤1.5mg/dL or creatinine clearance >60 mL/min, and alanine aminotransferase (ALT), aspartate transaminase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement. The subject is capable of understanding and complying with the protocol and has signed the informed consent document. Sexually active subjects must use an accepted method of contraception during the course of the study. Female patients of childbearing potential must have a negative pregnancy test at enrollment. If a subject has received more than three prior regimens of cytotoxic chemotherapy, or more than two biological regimens, or more than 3000cGy to areas containing substantial marrow, the cohort review committee (CRC) must determine subject suitability prior to enrollment. Exclusion Criteria: The subject has received chemotherapy or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to entering the study. The subject has received anti-angiogenesis drugs within 4 weeks prior to entering the study. The subject has received radiation to ≥25% of his or her bone marrow within 4 weeks of C31510IV treatment. The subject has received an investigational drug within 30 days of the first dose of study drug. 6 of 72 The subject has not recovered to grade ≤1 from adverse events( AEs) due to investigational drugs or other medications, which were administered more than 4 weeks prior to study enrollment. The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. The subject is pregnant or lactating. The subject is known to be positive for the human immunodeficiency virus (HIV) The subject has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee. Must have not taken Vitamin D3 supplements in the last 30 days The subject is on HMG-CoA Reductase Inhibitors The subject is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids The subject is receiving Colony Stimulating factors. The use of Colony Stimulating factors isf prohibited during the monitoring of DLT in this study. The subject is receiving Warfarin.
Facility Information:
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States

12. IPD Sharing Statement

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Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors

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