Adenosquamous Lung CarcinomaPhase 2NCT01294306
MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy
A Phase 2 study testing Akt Inhibitor MK2206, Erlotinib Hydrochloride and Laboratory Biomarker Analysis in people with Adenosquamous Lung Carcinoma and Bronchioloalveolar Carcinoma, run by National Cancer Institute (NCI) at 7 sites in United States.
Trial summary
This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer who have progressed after previous response to erlotinib hydrochloride therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenosquamous Lung Carcinoma, Bronchioloalveolar Carcinoma, Large Cell Lung Carcinoma
- What is being tested?
- Akt Inhibitor MK2206, Erlotinib Hydrochloride and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2011to Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically or cytologically confirmed non-small cell lung cancer of any histologic subtype
- NOTE: epidermal growth factor receptor (EGFR) mutational status (either wild-type or positive for an activating mutation) will be determined for all patients on this study; commercial assays for EGFR mutation status are allowed; knowledge of EGFR mutational status is not required at the time of protocol entry but should be determined or known before the end of course 2; however, if one of the strata is temporarily closed to accrual, knowledge of EGFR mutational status will be required prior to protocol entry
- Patients may have measurable or non-measurable disease; x-rays and/or scans for disease assessment of measurable disease must have been completed within 28 days prior to registration
- Patients must have radiologic or clinical progressive disease following prior benefit (response or stable disease) to EGFR-tyrosine kinase inhibitor (TKI) therapy (e.g., erlotinib) administered either as a single agent or in combination with other agents for at least 12 weeks prior to progression; Note: patients may have received intervening systemic therapy after EGFR-TKI progression); additionally, patients must have documentation of radiographic progression within the preceding three months prior to study entry
- Prior cytotoxic chemotherapy is allowed; any number of prior chemotherapy regimens is also allowed; prior cetuximab therapy is also allowed; NOTE: a patient with an EGFR activating mutation who has received EGFR-TKI therapy as first line therapy, but has not received platinum-based chemotherapy, would be considered eligible for this trial
- Karnofsky performance status >= 60%
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- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelet count >= 100,000/mcL
- Total bilirubin =< upper institutional normal limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
- Creatinine =< upper institutional normal limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Prior to the first patient registration, this study must be institutional review board approved; a copy of the institutional review board (IRB) approval for each site involved must be given to the Data Coordinating Center at City of Hope
- Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately
- Patients on coumadin should have their international normalized ratio (INR) monitored at least once per week or more frequently depending on the investigator's judgment; there have been some case reports of increased INR when coumadin is co-administered with erlotinib
- Ability to understand and the willingness to sign a written informed consent document
- Patients should have tumor tissue (either fresh frozen tumor tissue or paraffin-embedded tumor tissue) available for retrieval; if an endobronchial lesion is present or suspected, bronchoscopy is recommended as a source of fresh tissue; tissue blocks or unstained slides from the time of original diagnosis are acceptable if repeat biopsy is not feasible
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have any ongoing grade 2 or greater toxicity from a prior treatment
- Patients may not be receiving any other investigational agents
- Patients with symptomatic brain metastases should be excluded from this clinical trial; patients with asymptomatic controlled or treated (e.g., with radiation and/or surgery) brain metastases are otherwise eligible as long as corticosteroids given expressly for brain metastases (mets) have been stopped for at least 14 days
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or erlotinib
- Caution must be observed for patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4); although these patients are still potentially eligible, close monitoring is required for toxicity
- Preclinical studies demonstrated the potential of MK-2206 for induction of hyperglycemia in all preclinical species tested; patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial
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- Preclinical studies indicated transient changes in corrected QT (QTc) interval during MK-2206 treatment; prolongation of QTc interval is potentially a safety concern while on MK-2206 therapy; cardiovascular: baseline Fridericia QT (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with this combination
- Human immunodeficiency (HIV)-positive patients on combination antiretroviral therapy are ineligible
- Prior MK-2206 therapy is not allowed
- Patients unable to swallow MK-2206 tablets and erlotinib tables whole are ineligible; (the tablets cannot be crushed or broken)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
City of Hope South Pasadena
South Pasadena, California, 91030
About this study
Official title: Phase II Trial of the Akt Inhibitor MK-2206 Plus Erlotinib (OSI-774) in Patients With Advanced Non-small Cell Lung Cancer Who Have Progressed After Previous Response (Including Stable Disease) With Erlotinib Therapy
This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer who have progressed after previous response to erlotinib hydrochloride therapy. MK2206 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy (with the primary endpoint of disease control at 12 weeks) and tolerability of the combination of MK2206 plus erlotinib (erlotinib hydrochloride) in previously erlotinib-treated patients with recurrent or progressive advanced non-small cell lung cancer (NSCLC) whose tumors are either epidermal growth factor receptor (EGFR) mutated or EGFR wild-type.
SECONDARY OBJECTIVES:
- To determine progression-free survival of previously erlotinib-treated patients with NSCLC who are treated with MK2206 plus erlotinib. II. To determine the overall survival of previously erlotinib-treated patients with NSCLC who are treated with MK2206 plus erlotinib.
III. To assess the toxicity experienced by previously erlotinib-treated patients with NSCLC treated with MK2206 plus erlotinib. IV. To perform correlative analysis of tumor biomarkers to assess, in a preliminary manner, the association between tumor mutations and/or abnormalities and clinical outcome of previously erlotinib-treated patients with NSCLC treated with MK2206 plus erlotinib.
OUTLINE:
Patients receive Akt inhibitor MK2206 orally (PO) every other day (QOD) of a 28-day course, and erlotinib hydrochloride PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 12 weeks for one year and then annually thereafter.
- Conditions
- Adenosquamous Lung Carcinoma, Bronchioloalveolar Carcinoma, Large Cell Lung Carcinoma, Lung Adenocarcinoma, Recurrent Non-Small Cell Lung Carcinoma, Squamous Cell Lung Carcinoma
- Being tested
- Akt Inhibitor MK2206, Erlotinib Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Medical subject headings
- Adenocarcinoma, Bronchiolo-Alveolar, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akt Inhibitor MK2206Drug
Also called MK2206
Given PO
Erlotinib HydrochlorideDrug
Also called Cp-358,774, OSI-774, Tarceva
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Akt inhibitor MK2206, erlotinib hydrochloride) | Experimental | Patients receive Akt inhibitor MK2206 PO QOD of a 28-day course, and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Akt Inhibitor MK2206; Drug: Erlotinib Hydrochloride; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-control Rate
Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Measured: At 12 weeks
Objective Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR
Measured: Up to 2 years
Secondary outcomes (3)
Median Progression-free Survival
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 2 years
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride
Toxicities of Grade 3 or higher Attributed to Akt inhibitor MK2206 plus erlotinib hydrochloride, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Measured: Time Frame: Up to 2 years
Median Overall Survival
Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenosquamous Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Primo Lara, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294306
- Sponsor's protocol ID
- NCI-2011-02578
- Other IDs
- NCI-2011-02578, CDR0000695056, CHNMC-PHII-108, PhII-108, 8698, N01CM00038, N01CM00071, N01CM62209
- Status last verified
- Oct 2016
- First submitted
- 10 Feb 2011
- Last updated
- 29 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of the Akt Inhibitor MK-2206 Plus Erlotinib (OSI-774) in Patients With Advanced Non-small Cell Lung Cancer Who Have Progressed After Previous Response (Including Stable Disease) With Erlotinib Therapy
- ClinicalTrials.gov ID
- NCT01294306
- Acronym / sponsor ID
- NCI-2011-02578
- Conditions
- Adenosquamous Lung Carcinoma, Bronchioloalveolar Carcinoma, Large Cell Lung Carcinoma, Lung Adenocarcinoma, Recurrent Non-Small Cell Lung Carcinoma, Squamous Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 17 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies the side effects and how well Akt inhibitor MK2206 (MK2206) and erlotinib hydrochloride works in treating patients with advanced non-small cell lung cancer who have progressed after previous response to erlotinib hydrochloride therapy. MK2206 and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy (with the primary endpoint of disease control at 12 weeks) and tolerability of the combination of MK2206 plus erlotinib (erlotinib hydrochloride) in previously erlotinib-treated patients with recurrent or progressive advanced non-small cell lung cancer (NSCLC) whose tumors are either epidermal growth factor receptor (EGFR) mutated or EGFR wild-type.
SECONDARY OBJECTIVES:
- To determine progression-free survival of previously erlotinib-treated patients with NSCLC who are treated with MK2206 plus erlotinib. II. To determine the overall survival of previously erlotinib-treated patients with NSCLC who are treated with MK2206 plus erlotinib.
III. To assess the toxicity experienced by previously erlotinib-treated patients with NSCLC treated with MK2206 plus erlotinib. IV. To perform correlative analysis of tumor biomarkers to assess, in a preliminary manner, the association between tumor mutations and/or abnormalities and clinical outcome of previously erlotinib-treated patients with NSCLC treated with MK2206 plus erlotinib.
OUTLINE:
Patients receive Akt inhibitor MK2206 orally (PO) every other day (QOD) of a 28-day course, and erlotinib hydrochloride PO once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 12 weeks for one year and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Akt inhibitor MK2206, erlotinib hydrochloride) | Experimental | Drug: Akt Inhibitor MK2206, Drug: Erlotinib Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyPatients receive Akt inhibitor MK2206 PO QOD of a 28-day course, and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically or cytologically confirmed non-small cell lung cancer of any histologic subtype
- Patients may have measurable or non-measurable disease; x-rays and/or scans for disease assessment of measurable disease must have been completed within 28 days prior to registration
- Patients must have radiologic or clinical progressive disease following prior benefit (response or stable disease) to EGFR-tyrosine kinase inhibitor (TKI) therapy (e.g., erlotinib) administered either as a single agent or in combination with other agents for at least 12 weeks prior to progression; Note: patients may have received intervening systemic therapy after EGFR-TKI progression); additionally, patients must have documentation of radiographic progression within the preceding three months prior to study entry
- Prior cytotoxic chemotherapy is allowed; any number of prior chemotherapy regimens is also allowed; prior cetuximab therapy is also allowed; NOTE: a patient with an EGFR activating mutation who has received EGFR-TKI therapy as first line therapy, but has not received platinum-based chemotherapy, would be considered eligible for this trial
- Karnofsky performance status >= 60%
Key exclusion criteria (12 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have any ongoing grade 2 or greater toxicity from a prior treatment
- Patients may not be receiving any other investigational agents
- Patients with symptomatic brain metastases should be excluded from this clinical trial; patients with asymptomatic controlled or treated (e.g., with radiation and/or surgery) brain metastases are otherwise eligible as long as corticosteroids given expressly for brain metastases (mets) have been stopped for at least 14 days
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or erlotinib
- Caution must be observed for patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 450 3A4); although these patients are still potentially eligible, close monitoring is required for toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Akt Inhibitor MK2206Also: MK2206Given PO | Drug | Treatment (Akt inhibitor MK2206, erlotinib hydrochloride) |
| Erlotinib HydrochlorideAlso: Cp-358,774, OSI-774, TarcevaGiven PO | Drug | Treatment (Akt inhibitor MK2206, erlotinib hydrochloride) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (Akt inhibitor MK2206, erlotinib hydrochloride) |
| Pharmacological StudyCorrelative studies | Other | Treatment (Akt inhibitor MK2206, erlotinib hydrochloride) |
Primary outcome
Disease-control Rate
Time frame: At 12 weeks
Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Objective Response
Time frame: Up to 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR
3 secondary outcomes
Median Progression-free Survival
Time frame: Up to 2 years
Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride
Time frame: Time Frame: Up to 2 years
Median Overall Survival
Time frame: Up to 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Primo Lara principal investigator
University of California, Davis
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Akt Inhibitor MK2206, Erlotinib Hydrochloride and Laboratory Biomarker Analysis in people with Adenosquamous Lung Carcinoma and Bronchioloalveolar Carcinoma, run by National Cancer Institute (NCI) at 7 sites in United States.
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 16 inclusion and 12 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease-control Rate (time frame: At 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2016.