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A Phase 1 Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) When Administered to Patients With Advanced Solid Tumors


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

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Trial Information

A Phase 1 Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Lipotecan® (TLC388 HCl for Injection) When Administered to Patients With Advanced Solid Tumors


Lipotecan® is a drug product of TLC388 HCl, which is a potent camptothecin analog with
cytotoxic activities against a variety of human tumor cell lines in vitro and anti-tumor
activities in several xenograft models with human tumor cell lines. Structurally, TLC388
HCl is related to other camptothecins, but it has been chemically modified to improve
stability and potency, and to minimize toxicities.


Inclusion Criteria:



- Adult patients defined by age ≥18 years.

- Pathologically confirmed advanced solid tumors for which standard therapy proven to
provide clinical benefit does not exist or is no longer effective

- Evaluable disease, either measurable on imaging or with informative tumor marker(s),
by RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

Exclusion Criteria:

- Pregnancy or lactation. Women of childbearing potential must have a negative
pregnancy test within 7 days prior to enrolment. Male and female patients of
childbearing potential must agree to use appropriate birth control (barrier methods
with spermicides, oral or parenteral contraceptives and/or intrauterine devices)
during the entire duration of the study, or the patient must be surgically sterile
(with documentation in the patient's medical records).

- Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ
of the uterine cervix, unless the tumor was treated with curative intent more than 2
years prior to study entry.

- Receipt of more than 3 prior regimens of chemotherapy.

- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
prior to baseline. Receipt of radiotherapy to >25 % of bone marrow. Major surgery
within 4 weeks prior to baseline.

- Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents
which are potent inhibitors or inducers of cytochrome P450 enzymes unless approved by
the Sponsor.

- Uncontrolled intercurrent illness that would jeopardize patient safety, interfere
with the objectives of the protocol, or limit patient compliance with study
requirements, as determined by the Investigator.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Lipotecan

Outcome Description:

MTD is the highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT)). A 3+3 study design was used to determine MTD. The MTD was the highest dose level at which 0 of 3 or 1 of 6 patients experience a DLT, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.

Outcome Time Frame:

First treatment to toxicity up to 42 days

Safety Issue:

Yes

Principal Investigator

Min-Hsiung Kao

Investigator Role:

Study Director

Investigator Affiliation:

Taiwan Liposome Company, Ltd.

Authority:

United States: Food and Drug Administration

Study ID:

TLC388-101

NCT ID:

NCT00747474

Start Date:

September 2008

Completion Date:

December 2011

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

Name

Location

Montefiore Medical CenterBronx, New York  10467-2490
Medical College of GeorgiaAugusta, Georgia  30912
Bidmc, Dfci, MghBoston, Massachusetts  02215