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A Phase 1b Study to Assess the Safety, Feasibility, Pharmacokinetics, and Activity of PTC299 Monotherapy or Combination Therapy With Hormonal Agents in Patients With Metastatic Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

A Phase 1b Study to Assess the Safety, Feasibility, Pharmacokinetics, and Activity of PTC299 Monotherapy or Combination Therapy With Hormonal Agents in Patients With Metastatic Breast Cancer


The study will be conducted in 2 stages. In Stage 1 of the study, successive groups of 3 to
6 patients will receive progressively higher PTC299 dose levels; in this stage, treatment
will be given in repeated 6-week cycles consisting of 4 weeks of oral PTC299 twice per day
followed by a 2-week, no-drug period. During Stage 2, study candidates must be women with
natural or induced suppression of ovarian function to post-menopausal levels who are
receiving or are candidates for hormonal therapy. These subjects will receive continuous
administration of PTC299, 100 mg/dose BID, in repeated 6-week cycles in combination with
continuous administration of one of 3 hormonal agents. All planned PTC299 dose levels in
all stages are expected to achieve circulating blood levels of PTC299 known to be active in
animal models of human cancer. Treatment for each patient can continue as long as the
therapy appears to be safely offering tumor control to that patient. Up to 36 evaluable
patients will be accrued across both stages.

Inclusion Criteria


Major Eligibility Criteria:

1. Female sex.

2. Age ≥18 years.

3. Body weight 40-100 kg.

4. ECOG performance status of 0 or 1.

5. Histologically or cytologically confirmed adenocarcinoma of the breast.

6. Presence of metastatic disease not amenable to surgery, radiation therapy, or
chemoradiotherapy with curative intent.

7. No active second metastatic malignancy other than breast cancer.

8. No unstable brain or leptomeningeal disease.

9. Discontinuation of other therapies (except for anastrozole, letrozole, or exemestane)
for the treatment of breast cancer and resolution of any acute toxic effects of prior
therapies.

10. Adequate bone marrow, liver, and kidney function.

11. No uncontrolled hypertension, major bleeding, HIV infection or recent acute
cardiovascular event.

12. If sexually active and not postmenopausal or surgically sterile, willingness to
abstain from sexual intercourse or employ an effective barrier method of
contraception during the study drug administration and follow-up periods.

13. No pregnancy or breast-feeding.

14. Willingness and ability to comply with scheduled visits, drug administration plan,
laboratory tests, other study procedures, and study restrictions.

15. Willingness to provide informed consent. In addition to the criteria noted above,
Stage 2 subjects must also have natural or induced suppression of ovarian function to
post-menopausal levels and be receiving or be a candidate for hormonal therapy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD) within the tested dose range.

Outcome Time Frame:

6 Weeks

Safety Issue:

Yes

Principal Investigator

Jay Barth, MD

Investigator Role:

Study Director

Investigator Affiliation:

PTC Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

PTC299-ONC-003-BRC

NCT ID:

NCT00508586

Start Date:

November 2007

Completion Date:

March 2012

Related Keywords:

  • Metastatic Breast Cancer
  • Breast cancer
  • PTC299
  • VEGF
  • Angiogenesis
  • Post-transcriptional control
  • Aromatase inhibitors
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
New York University Clinical Cancer CenterNew York, New York  10016
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202