Know Cancer

forgot password

A Phase II Study of Ridaforolimus in Patients With Metastatic And/Or Locally Advanced Recurrent Endometrial Cancer

Phase 2
18 Years
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

A Phase II Study of Ridaforolimus in Patients With Metastatic And/Or Locally Advanced Recurrent Endometrial Cancer


- To assess the efficacy, in terms of objective response rate, of ridaforolimus, in
patients with recurrent metastatic and/or locally advanced endometrial cancer.

- To assess the adverse events, time to progression, and response duration of this drug
in these patients.

- To correlate objective tumor response with PTEN expression and other potential markers
in primary tumor tissue from these patients.

OUTLINE: This is a multicenter study.

Patients receive oral ridaforolimus once daily on days 1-5 for 4 weeks. Courses repeat every
4 weeks in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue samples (paraffin block or unstained slides) are analyzed for PTEN
gene expression and other mTOR pathway elements to explore possible markers of response or
non-progression by immunohistochemistry.

After completion of study treatment, patients are followed at 4 weeks and then every 3
months thereafter.

Inclusion Criteria


- Histologically confirmed endometrial cancer, including any 1 of the following

- Adenocarcinoma

- Papillary serous

- Papillary

- Villoglandular

- Mucinous

- Clear cell

- Endometrioid

- Adenosquamous carcinoma

- Recurrent or metastatic and/or locally advanced disease

- Incurable disease by standard therapies

- Clinically and/or radiologically documented disease within the past 28 days (35 days
if negative), defined as ≥ 1 unidimensionally measurable disease site meeting 1 of
the following criteria:

- At least 20 mm by x-ray or physical exam

- At least 10 mm by spiral CT scan

- At least 20 mm by non-spiral CT scan

- Available tumor tissue (paraffin block or unstained slides) from primary tumor

- No uterine sarcoma (leiomyosarcoma), mixed müllerian tumor (MMT), and/or adenosarcoma

- No known brain metastases

- Clinical suspicion of CNS involvement requires a head CT scan


- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- Granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ upper limit of normal (ULN)

- ALT and AST ≤ 2.5 times ULN

- Creatinine ≤ 1.25 times ULN OR creatinine clearance ≥ 50 mL/min

- Fasting serum cholesterol ≤ 9.0 mmol/L

- Fasting triglycerides ≤ 4.56 mmol/L

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Accessible for treatment and follow up (e.g., 1 ½ hours driving distance from
participating center)

- No upper gastrointestinal or other condition that would impair swallowing or
absorption of oral medication

- No serious illness or medical condition that would not permit the patient to be
managed according to the protocol, including, but not limited to, any of the

- History of significant neurologic or psychiatric disorder (e.g., uncontrolled
psychotic disorders) that would impair the ability to obtain consent or limit
compliance with study requirements

- Active uncontrolled or serious infection

- Active peptic ulcer disease

- Myocardial infarction within the past 6 months, congestive heart failure (even
if medically controlled), unstable angina, active cardiomyopathy, unstable
ventricular arrhythmia, or uncontrolled hypertension

- Pulmonary disease requiring oxygen

- HIV infection or other immune deficiency

- Other medical conditions that might be aggravated by study treatment

- No history of other malignancies, except adequately treated nonmelanoma skin cancer,
curatively treated carcinoma in situ of the cervix, or other solid tumors curatively
treated with no evidence of disease for ≥ 5 years

- No known hypersensitivity to the study drug or its components


- At least 7 days since prior hormonal therapy (progestational or aromatase inhibitor)
as either adjuvant therapy or for treatment of metastatic disease

- At least 21 days since prior major surgery and recovered

- At least 28 days since prior radiotherapy and recovered

- Prior low-dose palliative radiotherapy allowed

- At least 4 months since prior adjuvant chemotherapy

- No prior mTOR inhibitors

- No prior or concurrent chemotherapy for metastatic or recurrent disease

- More than 7 days since prior and no concurrent CYP3A4 inhibitors including, but not
limited to, any of the following:

- Azole antifungals (i.e., ketoconazole, itraconazole, miconazole, fluconazole)

- HIV protease inhibitors (i.e., indinavir, saquinavir, ritonavir, atazanavir,

- Clarithromycin

- Verapamil

- Erythromycin

- Delavirdine

- Diltiazem

- Nefazodone

- Telithromycin

- More than 12 days since prior and no concurrent CYP3A4 inducers including, but not
limited to, any of the following:

- Rifampin

- Phenytoin

- Rifabutin

- St. John's wort

- Carbamazepine

- Efavirenz

- Phenobarbital

- Tipranavir

- At least 14 days since prior and no concurrent investigational drugs or anticancer
therapy (e.g., immunotherapy, biological response modifiers [excluding hematopoietic
growth factors], and systemic hormonal therapy)

- No concurrent CYP3A4 substrates

Type of Study:


Study Design:

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

Outcome Measure:

Objective response measured by RECIST criteria

Outcome Description:

After every second cycle

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator

Amit M. Oza, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Health Canada

Study ID:




Start Date:

August 2008

Completion Date:

February 2014

Related Keywords:

  • Endometrial Cancer
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial clear cell carcinoma
  • endometrial papillary carcinoma
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma