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A Phase 1B/2A, Open-label, Non-randomized, Multi-arm Study of TL32711 in Combination With Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer

Thank you

Trial Information

A Phase 1B/2A, Open-label, Non-randomized, Multi-arm Study of TL32711 in Combination With Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors


The purpose of this study is to determine the safety and maximum tolerated dose of TL32711
as a 30 minute intravenous infusion once a week, for 2 consecutive weeks, when combined with
standard regimens of chemotherapy in subjects with advanced or metastatic solid tumors.
Additionally the study will assess anti-tumor activity, pharmacokinetics, and exploratory
biomarkers as a measurement of pharmacodynamic effects.


Inclusion Criteria:



- Confirmed advanced or metastatic malignancy for which the proposed chemotherapy
regimen is appropriate in the judgment of the Investigator.

- Prior therapy in dose-escalation and expansion cohorts:

- Dose-escalation cohorts: Subjects may be naïve or may have received prior
therapy with the specific chemotherapeutic agent(s) being recommended in the
combination arm, provided the subject did not experience life-threatening
toxicity attributed to the specific agent(s).

- Expansion cohorts: Subjects may not have received prior therapy with the
specific combination chemotherapeutic agent(s) in the expansion arm. No more
than 2 prior cytotoxic chemotherapy regimens for advanced or metastatic disease
are allowed.

- Subjects evaluated for Arm 5 (liposomal doxorubicin) may not have received >300 mg/m2
cumulative dose of anthracycline.

- Life expectancy >3 months.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

- Adequate renal function

- Adequate hepatic function

- Adequate bone marrow function

- Women of childbearing potential must have a negative serum pregnancy test.

- Women of childbearing potential must agree to use 2 methods of adequate contraception
(ie, hormonal and barrier method) prior to enrollment, during the study, and for a
period of 30 days following the last dose of TL32711. Males who are sexually active
must agree to use a condom during the study and for a period of 30 days following the
last dose of TL32711, and if their partner is of childbearing potential, she must
agree to use a secondary method of contraception (ie, hormonal, intrauterine device,
barrier) during the study and for a period of 30 days following the last dose of
TL32711.

Exclusion Criteria:

- Recent anti-cancer treatment defined as:

- Standard or investigational anti-cancer therapy within 4 weeks prior to first dose of
TL32711. Exception: continued hormonal interventions for prostate cancer.

- Radiation therapy within 2 weeks prior to the first dose of TL32711.

- Major surgery within 4 weeks prior to the first dose of TL32711. Subjects must be
well recovered from acute effects of surgery prior to enrollment.

- Known or suspected diagnosis of human immunodeficiency virus or chronic active
Hepatitis B or C.

- Symptomatic or uncontrolled brain metastases requiring current treatment.

- Impaired cardiac function or clinically significant cardiac disease including the
following:

- QT interval corrected for heart rate (QTcB) >480 msec (including subjects on
medication).

- Lack of recovery of prior adverse events to Grade ≤1 severity (NCI CTCAE v4) (except
alopecia) due to therapy administered prior to the initiation of study drug dosing.

- Nursing or pregnant women.

- Known allergy to any of the formulation components of TL32711.

- Any concurrent disease and/or medical condition that in the opinion of the
Investigator that would prevent the subject's participation, render the subject at
excessive risk (including excessive risks due to the toxicity profile of the planned
combination chemotherapeutic regimen), or limit the subject's compliance with the
protocol's required evaluations.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of subjects with adverse events as a measure of safety and tolerability

Outcome Description:

Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

Outcome Time Frame:

1 Cycle (3-4 weeks)

Safety Issue:

Yes

Principal Investigator

Neil N Senzer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mary Crowley Medical Research Center

Authority:

United States: Food and Drug Administration

Study ID:

TL32711-POC-0078-PTL

NCT ID:

NCT01188499

Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Cancer

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Mary Crowley Medical Research CenterDallas, Texas  75246
University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104
South Texas Accelerated Research Therapeutics (START)San Antonio, Texas  78229
Barbara Ann Karmanos Cancer CenterDetroit, Michigan  48201