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Non-Small Cell Lung CancerPhase 2NCT00818675

A Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)

A Phase 2 study testing Lead-In Ridaforolimus and Comparator: Blinded Ridaforolimus in people with Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Lead-In Ridaforolimus and Comparator: Blinded Ridaforolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
No sites listed yet
Study dates
Mar 2009to Aug 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has histologically confirmed stage IIIB/IV non-small cell lung cancer
  • Patient has a documented mutation of the KRAS gene
  • Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
  • A minimum of 4 weeks has passed since the most recent anti-cancer treatment
  • Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
  • Patient has adequate organ function
  • Patient has performance status of <=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
  • Patient is >=18 years of age

Who cannot join

  • Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
  • Patient is known to have active brain metastases
  • Patient is currently participating or has participated in an investigational drug study within 30 days
  • Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
  • Patient has an active infection requiring prescribed intervention
  • Patient has newly diagnosed or un-controlled Type 1 or 2 diabetes

About this study

Official title: A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations

This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo. Patients assessed to have partial or complete response will continue on open-label ridaforolimus. Patients assessed to have disease progression will be discontinued from study.

Read the detailed description

Allocation and Arms Additional Information: All Patients will receive an 8-week

open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)

Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.

Being tested
Lead-In Ridaforolimus, Comparator: Blinded Ridaforolimus, Comparator: Blinded Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Lead-In RidaforolimusDrug

    Also called MK-8669; AP23573, Deforolimus (until May, 2009)

    Four 10mg tablets of ridaforolimus once daily for five consecutive days each week followed by 2 days days of treatment holiday, during the 8 week lead in treatment period.

  • Comparator: Blinded RidaforolimusDrug

    Also called MK-8669; AP23573, Deforolimus (until May, 2009)

    Four tablets of blinded ridaforolimus administered daily for 5 consecutive days each week followed by 2 days days of treatment holiday

  • Comparator: Blinded PlaceboDrug

    Four tablets of blinded placebo (to match ridaforolimus) administered daily for 5 consecutive days each week followed by 2 days of treatment holiday

Study groups in NCT00818675
Study groupRoleWhat they receive
RidaforolimusExperimentalNot described
Receives: Drug: Lead-In Ridaforolimus; Drug: Comparator: Blinded Ridaforolimus
PlaceboPlacebo comparatorNot described
Receives: Drug: Lead-In Ridaforolimus; Drug: Comparator: Blinded Placebo

What is being measured

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

  1. Progression-free survival (PFS) in the randomized population

    Measured: Randomization (Week 8) and every 8 weeks until progressive disease or death

Secondary outcomes (4)

  1. Overall response rate (ORR) in the full analysis population

    Measured: Study entry (Visit 1) and every 8 weeks until progressive disease or death

  2. Overall survival (OS) in the full analysis population

    Measured: From study entry (Visit 1) to death due to any cause

  3. OS in the randomized population

    Measured: From study entry (Visit 1) to death due to any cause

  4. PFS in the full analysis population

    Measured: Study entry (Visit 1) and every 8 weeks until progressive disease or death

Timeline

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

  1. First posted8 Jan 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionAug 2012
  4. Study completionAug 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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00818675
Sponsor's protocol ID
8669-021
Other IDs
2008_599
Status last verified
Jan 2015
First submitted
7 Jan 2009
Last updated
21 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lead-In Ridaforolimus and Comparator: Blinded Ridaforolimus in people with Non-Small Cell Lung 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Jan 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.

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) in the randomized population (time frame: Randomization (Week 8) and every 8 weeks until progressive disease or death). 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 NCT00818675.

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 21 Jan 2015.

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