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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Assessment

Outcome 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.

Outcome 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.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CTL0510

NCT ID:

NCT01251562

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Solid Tumors
  • Neoplasms

Name

Location

Sarcoma Oncology CenterSanta Monica, California  90403