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Endometrial CancerPhase 2NCT00739830

Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)

A Phase 2 study testing ridaforolimus, medroxyprogesterone acetate tablets OR megestrol acetate and chemotherapy in people with Endometrial Cancer, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one, but not more than two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced disease, and then when treated with ridaforolimus… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
ridaforolimus, medroxyprogesterone acetate tablets OR megestrol acetate and chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
No sites listed yet
Study dates
Aug 2008to Jul 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Endometrial cancer
  • Patients must have been treated with at least one line of chemotherapy, but not more than two lines of chemotherapy, and experienced progressive disease
  • At least one measurable lesion
  • ECOG performance status less than or equal to 1
  • Minimum life expectancy of 3 months
Show all 11Show fewer
  • Adequate renal and hepatic function
  • Adequate bone marrow function
  • Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
  • Able to understand and give written informed consent
  • Females of childbearing potential must have a negative pregnancy test and use approved contraception from screening to 30 days after the last study drug is given

Who cannot join

  • Two lines of chemotherapy for recurrent or metastatic disease
  • Chemotherapy for recurrent or metastatic disease administered within six months of adjuvant therapy
  • More than two lines of chemotherapy of any type
  • Prior therapy with hormonal agents
  • Women who are pregnant or lactating
  • Presence of brain or other central nervous system metastases
Show all 19Show fewer
  • Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents
  • Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization
  • Ongoing toxicity associated with prior anticancer therapy
  • Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization.
  • Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ)
  • Known Grade 3 or 4 hypersensitivity to macrolide antibiotics
  • Significant uncontrolled cardiovascular disease
  • Active infection
  • Known HIV infection
  • Known Hepatitis B or C infection
  • Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes
  • Concurrent treatment with immunosuppressive agents
  • A requirement for concurrent treatment with medication that strongly induce or inhibit cytochrome P450 (CYP3A)

About this study

Official title: A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma

The purpose of this study is to compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one, but not more than two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced disease, and then when treated with ridaforolimus or the investigators' choice of progestin or chemotherapy.

Being tested
ridaforolimus, medroxyprogesterone acetate tablets OR megestrol acetate, chemotherapy
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ridaforolimusDrug

    Also called deforolimus, AP23573, MK-8669; ridaforolimus was also known as deforolimus until May 2009

    40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus

  • medroxyprogesterone acetate tablets OR megestrol acetateDrug

    oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)

  • chemotherapyDrug

    Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator

Study groups in NCT00739830
Study groupRoleWhat they receive
1Experimental40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
Receives: Drug: ridaforolimus
2Active comparatorInvestigator's choice of: oral medroxyprogesterone acetate tablets 200 mg daily or oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily) OR Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator
Receives: Drug: medroxyprogesterone acetate tablets OR megestrol acetate; Drug: chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Measured: From randomization up to 30 months

Secondary outcomes (5)

  1. The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.

    Measured: From randomization to Week 16

  2. The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines

    Measured: From randomization to Week 26

  3. Overall survival

    Measured: From randomization up to 30 months

  4. Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression

    Measured: From randomization up to 30 months

  5. Safety and tolerability

    Measured: From randomization up to 30 days after discontinuation of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionFeb 2011
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00739830
Sponsor's protocol ID
8669-007
Other IDs
AP23573-07-205
Status last verified
Jun 2015
First submitted
20 Aug 2008
Last updated
1 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Oza AM, Pignata S, Poveda A, McCormack M, Clamp A, Schwartz B, Cheng J, Li X, Campbell K, Dodion P, Haluska FG. Randomized Phase II Trial of Ridaforolimus in Advanced Endometrial Carcinoma. J Clin Oncol. 2015 Nov 1;33(31):3576-82. doi: 10.1200/JCO.2014.58.8871. Epub 2015 Jun 15.

    PubMed 26077241

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ridaforolimus, medroxyprogesterone acetate tablets OR megestrol acetate and chemotherapy in people with Endometrial Cancer, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From randomization up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00739830, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015.

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