Lung CancerPhase 2NCT00988169
Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations
A Phase 2 study testing oral erlotinib and pulsed doses of oral AT-101 in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Advanced stage lung cancer is generally treated with anti-cancer medication called chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers develop in people who never smoked or who only smoked for a short period of time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- oral erlotinib and pulsed doses of oral AT-101
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2010
- 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
- Ability to understand and the willingness to sign a written informed consent form; the consent form must be signed by the patient prior to any study-specific procedures.
- Patients age ≥ 18 years with histologically confirmed wet Stage IIIB (with malignant pleural effusion) or Stage IV non-small cell lung cancer (metastatic or recurrent).
- Pathologic confirmation of non-small cell lung cancer at Memorial Sloan-Kettering Cancer Center.
- Presence of exon 19 or exon 21 EGFR activating mutation.
- No prior EGFR tyrosine kinase therapy.
- No prior systemic therapy for advanced NSCLC (Stage IIIB with malignant effusion or Stage IV)
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- Karnofsky performance status > or = to 70% OR ECOG performance status ≤ 2.
- Measurable disease defined as greater than or equal to one known/suspected malignant lesion > or = to 1 cm measurable in two dimensions.
- Adequate hematologic, renal, and/or hepatic function: WBC > or = to 3,000/ul, hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin ≤ 1.5 X UNL, AST ≤ 2.5 X UNL, and serum creatinine within 1.5 x the upper limit of normal (<1.95 at MSKCC) or calculated creatinine clearance > or = to 60 ml/min.
- Able to swallow and retain oral medication.
- Willingness and ability to comply with study procedures and follow-up examination.
- Four weeks since any major surgery, completion of radiation, or completion of all prior chemotherapy.
- Acute toxicities of any prior therapy must have resolved to < Grade 1 or baseline prior to starting study therapy.
- Effective contraception.
Who cannot join
- Prior treatment with gefitinib, erlotinib, or other EGFR tyrosine kinase inhibitor therapy.
- Concurrent cytotoxic or biological therapy.
- Known KRAS mutation.
- History within the past 6 months of myocardial infarction, cardiac stent placement, or intermittent ischemia with troponin leak.
- Active secondary malignancy or history of other malignancy within the last 3 years except non-melanoma skin cancer and in-situ carcinoma of the cervix.
- Active, serious comorbid medical conditions including severe infection, malnutrition, unstable angina, congestive heart failure (New York Heart Association Class III or IV), pulmonary fibrosis, or condition that would be felt by treating physician to preclude safe participation in the clinical trial.
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- Patients with malabsorption syndrome or diseases significantly affecting the gastrointestinal tract including prior gastric resection or small bowel resection, inflammatory bowel disease, or partial or complete small bowel obstruction.
- Unstable brain or leptomeningeal metastases including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
- Women who are pregnant or breast-feeding.
- Inability/unwillingness to comply with protocol treatment or follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase II Trial of Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Activating Mutations
Advanced stage lung cancer is generally treated with anti-cancer medication called chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers develop in people who never smoked or who only smoked for a short period of time. This type of lung cancer may respond to a medication called erlotinib (Tarceva). Erlotinib is an anticancer pill that is approved by the Food and Drug Administration (FDA) for use in patients with advanced lung cancer. Unfortunately, erlotinib does not work for all patients or only works for a period of time. The doctors are trying to find ways to improve the effect of erlotinib by combining it with another anti-cancer medication.
Ascenta Therapeutics, Inc. has developed a drug called AT-101 as a potential treatment for cancer. AT-101 is an investigational drug. That means that AT-101 is not approved by the United States Food and Drug Administration (FDA) for general use. The FDA does permit its use in studies like this one to determine whether it is safe and effective.
This is the first study to examine the effects of AT-101 and erlotinib. It is hoped that by combining AT-101 with erlotinib, AT-101 may help erlotinib work better to shrink lung cancer. Studies that have been performed in the laboratory suggest that AT-101 in combination with erlotinib may be more effective at shrinking tumors than erlotinib alone.
- Conditions
- Lung Cancer
- Being tested
- oral erlotinib and pulsed doses of oral AT-101
- Keywords
- AT-101, erlotinib, Unresectable Stage IIIB, 09-026
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral erlotinib and pulsed doses of oral AT-101Drug
Patients will receive oral erlotinib 100 mg daily and pulsed doses of oral AT-101 given 40 mg twice daily on days 1-3 of a 21-day cycle. If the initial combination of erlotinib and AT-101 is tolerated, dose escalation of erlotinib to 150 mg daily will be allowed at the discretion of the treating investigator at the start of cycle 2. Patients will continue receiving treatment on study until they refuse further therapy, develop evidence of progressive disease, or develop unacceptable toxicity or a medical condition that would, in the judgment of the investigator,
| Study group | Role | What they receive |
|---|---|---|
| oral erlotinib and pulsed doses of oral AT-101 | Experimental | This will be an open-label, single institution, phase II trial. The study will assess the efficacy of the combination of the epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib, and the novel pan-Bcl-2 inhibitor, AT-101, in treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations A planned pause of 21 days will be performed after enrollment of the 10th and 20th patient to assess for excessive toxicity. Receives: Drug: oral erlotinib and pulsed doses of oral AT-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Objective Response Rate
(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101
Measured: 21 days after cycle one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionMay 2010
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ascenta Therapeutics
- Responsible party
- Sponsor
- Investigators
- Naiyer Rizvi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988169
- Sponsor's protocol ID
- 09-026
- Status last verified
- Oct 2015
- First submitted
- 30 Sep 2009
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Activating Mutations
- ClinicalTrials.gov ID
- NCT00988169
- Acronym / sponsor ID
- 09-026
- Conditions
- Lung Cancer
- Keywords
- AT-101, erlotinib, Unresectable Stage IIIB, 09-026
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Ascenta Therapeutics
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advanced stage lung cancer is generally treated with anti-cancer medication called chemotherapy. Most lung cancer is caused by cigarette smoking. However, some lung cancers develop in people who never smoked or who only smoked for a short period of time. This type of lung cancer may respond to a medication called erlotinib (Tarceva). Erlotinib is an anticancer pill that is approved by the Food and Drug Administration (FDA) for use in patients with advanced lung cancer. Unfortunately, erlotinib does not work for all patients or only works for a period of time. The doctors are trying to find ways to improve the effect of erlotinib by combining it with another anti-cancer medication.
Ascenta Therapeutics, Inc. has developed a drug called AT-101 as a potential treatment for cancer. AT-101 is an investigational drug. That means that AT-101 is not approved by the United States Food and Drug Administration (FDA) for general use. The FDA does permit its use in studies like this one to determine whether it is safe and effective.
This is the first study to examine the effects of AT-101 and erlotinib. It is hoped that by combining AT-101 with erlotinib, AT-101 may help erlotinib work better to shrink lung cancer. Studies that have been performed in the laboratory suggest that AT-101 in combination with erlotinib may be more effective at shrinking tumors than erlotinib alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral erlotinib and pulsed doses of oral AT-101 | Experimental | Drug: oral erlotinib and pulsed doses of oral AT-101This will be an open-label, single institution, phase II trial. The study will assess the efficacy of the combination of the epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib, and the novel pan-Bcl-2 inhibitor, AT-101, in treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations A planned pause of 21 days will be performed after enrollment of the 10th and 20th patient to assess for excessive toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ability to understand and the willingness to sign a written informed consent form; the consent form must be signed by the patient prior to any study-specific procedures.
- Patients age ≥ 18 years with histologically confirmed wet Stage IIIB (with malignant pleural effusion) or Stage IV non-small cell lung cancer (metastatic or recurrent).
- Pathologic confirmation of non-small cell lung cancer at Memorial Sloan-Kettering Cancer Center.
- Presence of exon 19 or exon 21 EGFR activating mutation.
- No prior EGFR tyrosine kinase therapy.
Key exclusion criteria (10 listed)
- Prior treatment with gefitinib, erlotinib, or other EGFR tyrosine kinase inhibitor therapy.
- Concurrent cytotoxic or biological therapy.
- Known KRAS mutation.
- History within the past 6 months of myocardial infarction, cardiac stent placement, or intermittent ischemia with troponin leak.
- Active secondary malignancy or history of other malignancy within the last 3 years except non-melanoma skin cancer and in-situ carcinoma of the cervix.
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 |
|---|---|---|
| oral erlotinib and pulsed doses of oral AT-101Patients will receive oral erlotinib 100 mg daily and pulsed doses of oral AT-101 given 40 mg twice daily on days 1-3 of a 21-day cycle. If the initial combination of erlotinib and AT-101 is tolerated, dose escalation of erlotinib to 150 mg daily will be allowed at the discretion of the treating investigator at the start of cycle 2. Patients will continue receiving treatment on study until they refuse further therapy, develop evidence of progressive disease, or develop unacceptable toxicity or a medical condition that would, in the judgment of the investigator, | Drug | oral erlotinib and pulsed doses of oral AT-101 |
Primary outcome
Radiographic Objective Response Rate
Time frame: 21 days after cycle one
(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Naiyer Rizvi, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral erlotinib and pulsed doses of oral AT-101 in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 14 inclusion and 10 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 20 Nov 2015). 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?
Radiographic Objective Response Rate (time frame: 21 days after cycle one). 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 20 Nov 2015.