Recurrent Non-small Cell Lung CancerPhase 1NCT01839955
Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer
A Phase 1 study testing erlotinib hydrochloride, quinacrine dihydrochloride - Escalation dose and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by Neelesh Sharma MD PhD at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of quinacrine dihydrochloride when given together with erlotinib hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- What is being tested?
- erlotinib hydrochloride, quinacrine dihydrochloride - Escalation dose and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2016
- Phase
- Phase 1
- 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
- Patients must have histologically or cytologically confirmed incurable malignancy that is surgically unresectable locally advanced, recurrent, or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC). Patients with adenocarcinoma, squamous cell carcinoma, large cell carcinoma and sarcomatoid carcinoma will be eligible.
- Patients must have received at least one platinum-containing regimen for the treatment of advanced or metastatic disease (except for EGFR-mutant patients). Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen. NSCLC with documented EGFR mutation will be eligible after progression on an EGFR-TKI alone. NSCLC with other molecular targets, such as fusion gene involving the anaplastic lymphoma kinase (ALK) gene (such as echinoderm microtubule associated protein like 4 [EML4]-ALK) or ROS-1 will be eligible if they have progressed on targeted agents (ALK inhibitor) and chemotherapy or are not a candidate for chemotherapy. Adjuvant/neoadjuvant chemotherapy or chemoradiation is considered a line of therapy if < 12 months have elapsed between the last dose and the date of recurrence. Combined treatment with chemotherapy and radiation constitutes a single regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of ≥ 12 weeks, in the opinion of and as documented by the investigator
- Hemoglobin ≥ 9.0 g/dl (transfusion and/or growth factor support allowed)
- Absolute neutrophil count (ANC) ≥ 1,500/mcL
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- Platelet count ≥ 100 x 10^9 L
- Alkaline phosphatase < 2.5 X institutional upper limit of normal (in subjects with no liver metastasis and < 5.0 upper limit of normal [ULN] in subjects with liver metastasis)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal (in subjects with no liver metastasis and < 5.0 ULN in subjects with liver metastasis)
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Serum total bilirubin ≤ 1.5 x ULN OR total bilirubin ≤ 4.0 ULN with direct bilirubin ≤ 1.5 x ULN in patients with well documented Gilbert syndrome
- Patients who are receiving therapeutic anticoagulation with heparin are allowed to participate provided that no prior evidence of underlying abnormality exists in these parameters. Patients on warfarin are eligible provided they are on stable doses of warfarin and there is close monitoring of INR.
- Resolution of any toxic effects of prior therapy (including radiotherapy) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, grade ≤ 1 (with the exception of alopecia and ≤ grade 2 neuropathy); subject must have recovered from significant surgery-related complications
- Women of childbearing potential must have a negative pregnancy test performed within 48 hours prior to the start of the study drug
- Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) prior to study entry, for the duration of study participation and for 90 days after completing the last investigational drug dose; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with previous anti-cancer chemotherapy, immunotherapy or investigational agents ≤ 3 weeks prior to the first day of study defined treatment. NSCLC patients with EGFR mutation can enroll within 7 days of discontinuing EGFR-TKI. Palliative radiation < 1 week before the start of treatment (lesions subjected to radiotherapy may not be used as target lesions). Patients who receive gamma knife radiosurgery for brain metastases within 1 week prior to treatment start.
- Patients with unknown status of EGFR mutation (only for patients with adenocarcinoma histology)
- Patients that have had major surgery ≤ 3 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy, etc) ≤ 1 week prior to the first day of study defined treatment.
- History of cardiac disease: congestive heart failure defined as class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); previously diagnosed bradycardia or other cardiac arrhythmia defined as ≥ grade 2 according to NCI-CTCAE (version 4.0), or uncontrolled hypertension; myocardial infarction occurred within 6 months prior to study entry (myocardial infarction occurred > 6 months prior to study entry is permitted)
- Patients with clinically unstable central nervous system (CNS) metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by magnetic resonance imaging [MRI] or computed tomography [CT] scan within 4 weeks of the first day of study defined treatment and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications)
- Patients with significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption of quinacrine and/or erlotinib (eg, Crohn's disease, small or large bowel resection, malabsorption syndrome)
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- Patients with any known contraindication to treatment with, including hypersensitivity to quinacrine or erlotinib
- Patients with active clinically serious infections defined as ≥ grade 2 according to NCI CTCAE, version 4.0
- Patients with substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results
- Any other condition that is unstable or which could jeopardize the safety of the patient and his/her protocol compliance
- History of incurable malignancy other than NSCLC within the 5 years prior to start of treatment, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL; or basal or squamous-cell carcinoma of the skin.
- Pregnant or breastfeeding women and adults of reproductive potential not employing an effective method of birth control are excluded from this study because quinacrine is category N agent with the potential for teratogenic or abortifacient effects; these potential risks may also apply to other agents used in this study
- Patients with previously known infection with human immunodeficiency virus (HIV) or active viral hepatitis are ineligible because of the potential for pharmacokinetic interactions with quinacrine; (diagnostic testing for these infections will be done only if clinically indicated)
- Patients with known Glucose-6-phosphate deficiency, psoriasis, porphyria and psychosis (quinacrine may exacerbate the symptoms of these disorders)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer
Cleveland, Ohio, 44106
About this study
Official title: A Phase I Study of Erlotinib in Combination With Quinacrine in Patients With Advanced Non-Small-Cell Lung Cancer
This phase I trial studies the side effects and best dose of quinacrine dihydrochloride when given together with erlotinib hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as quinacrine dihydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib hydrochloride together with quinacrine dihydrochloride may kill more tumor cells
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and quinacrine (quinacrine dihydrochloride) in patients with advanced non-small-cell lung cancer.
II. To determine the recommended Maximum Tolerated Dose (MTD) of the combination of erlotinib and quinacrine in patients with advanced non-small-cell lung cancer.
SECONDARY OBJECTIVES:
- To describe the dose limiting toxicity of the erlotinib and quinacrine combination.
II. To determine the pharmacokinetic profile of the erlotinib and quinacrine combination.
III. To determine objective response rate (complete response [CR]+partial response [PR]) and clinical benefit rate (CR+PR+ stable disease [SD]) of the erlotinib and quinacrine combination.
IV. To estimate overall survival (OS)
OUTLINE: This is a phase I, dose escalation study of quinacrine dihydrochloride
Escalation Portion: Patients receive erlotinib hydrochloride orally (PO)daily on days 1-28 and quinacrine dihydrochloride PO thrice daily (TID) on days, 1-7 and PO daily from days 8-28.
After Maximum Tolerated Dose is established: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive erlotinib hydrochloride PO daily on days 1-28.
ARM II: Patients receive erlotinib hydrochloride PO and quinacrine dihydrochloride PO daily (TID) on days, 1-7 and PO daily from days 8-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Being tested
- erlotinib hydrochloride, quinacrine dihydrochloride - Escalation dose, laboratory biomarker analysis, pharmacological study, quinacrine dihydrochloride - Extension dose
- 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.
erlotinib hydrochlorideDrug
Also called CP-358,774, erlotinib, OSI-774
Dose Escalation Group:
Begins day 1: given 150mg daily, orally
Extension Group:
Begins Day 1: 150mg daily, orally
quinacrine dihydrochloride - Escalation doseDrug
Also called atabrine dihydrochloride, mepacrine dihydrochoride, SN 390
Begins Day 8: Loading dose (first cycle only) 50mg three times daily for 7 days followed by 21 days of 50mg maintenance dose. Level -1: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg every other day for three weeks). Level 1 [starting dose]: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg daily for three weeks). Level 2: Loading dose (100mg three times daily for 7 days), maintenance dose (100mg every other day for three weeks). Level 3: Loading dose (150mg three times daily for 7 days), maintenance dose (200mg every other day for three weeks). Level 4: Loading dose (200mg three times daily for 7 days), maintenance dose (400mg every other day for three weeks). Subsequent patient cohort(s) will be enrolled depending on the safety and tolerability of subjects
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
quinacrine dihydrochloride - Extension doseDrug
Also called atabrine dihydrochloride, mepacrine dihydrochoride, SN 390
Participants will be treated at recommended dose from expansion group to confirm tolerability and evaluate early response
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Dose Escalation Group) | Experimental | Erlotinib hydrochloride and quinacrine dihydrochloride. The first three or six patients will be entered in this part of the study. Then this part will end. Receives: Drug: erlotinib hydrochloride; Drug: quinacrine dihydrochloride - Escalation dose; Other: laboratory biomarker analysis; Other: pharmacological study |
| Arm II (Extension Group) | Experimental | Erlotinib hydrochloride and quinacrine dihydrochloride. The next 12 patients will enter into the second part of this study. Receives: Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis; Other: pharmacological study; Drug: quinacrine dihydrochloride - Extension dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of quinacrine dihydrochloride in combination of erlotinib hydrochloride determined by dose-limiting toxicities
Measured: 28 days
Progression Free Survival (PFS)
Estimated by Kaplan-Meier method and the difference between two treatment arms will be evaluated by log-rank test.
Measured: Date of randomization to the date of disease progression or the date of death, assessed up to 2 years
Secondary outcomes (5)
Pharmacokinetic parameters
Measured: after 2 months (2 cycles)
Objective tumor response rate (ORR) (complete response and partial response) evaluated by revised Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Estimated based on the number of responses by excluding the dropouts who are not evaluable for response using a binomial distribution.
Measured: Up to 2 years
Disease stabilization rate (complete response, partial response and stable disease)
The confidence intervals for them will be estimated using Wilson's method.
Measured: Up to 2 years
Baseline expression of intracellular inhibitor of the nuclear factor kappa B (IkappaB) or NFkappaB gene signature in determining survival or response
Measured: Baseline up to 2 years
Overall survival (OS)
Estimated by Kaplan-Meier method and the difference between two treatment arms will be evaluated by log-rank test. Identified by Cox model or extended Cox model. Chi-square test or Fisher's exact test will be used to examine the difference of response rate between two treatment arms.
Measured: Date of randomization to the date of death, assessed 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 posted25 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neelesh Sharma MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neelesh Sharma MD PhD, Case Comprehensive Cancer Center
- Investigators
- Neelesh Sharma, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839955
- Sponsor's protocol ID
- CASE8512
- Other IDs
- NCI-2013-00599
- Status last verified
- Oct 2016
- First submitted
- 23 Apr 2013
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Erlotinib in Combination With Quinacrine in Patients With Advanced Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01839955
- Acronym / sponsor ID
- CASE8512
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Neelesh Sharma MD PhDUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of quinacrine dihydrochloride when given together with erlotinib hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as quinacrine dihydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib hydrochloride together with quinacrine dihydrochloride may kill more tumor cells
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and quinacrine (quinacrine dihydrochloride) in patients with advanced non-small-cell lung cancer.
II. To determine the recommended Maximum Tolerated Dose (MTD) of the combination of erlotinib and quinacrine in patients with advanced non-small-cell lung cancer.
SECONDARY OBJECTIVES:
- To describe the dose limiting toxicity of the erlotinib and quinacrine combination.
II. To determine the pharmacokinetic profile of the erlotinib and quinacrine combination.
III. To determine objective response rate (complete response [CR]+partial response [PR]) and clinical benefit rate (CR+PR+ stable disease [SD]) of the erlotinib and quinacrine combination.
IV. To estimate overall survival (OS)
OUTLINE: This is a phase I, dose escalation study of quinacrine dihydrochloride
Escalation Portion: Patients receive erlotinib hydrochloride orally (PO)daily on days 1-28 and quinacrine dihydrochloride PO thrice daily (TID) on days, 1-7 and PO daily from days 8-28.
After Maximum Tolerated Dose is established: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive erlotinib hydrochloride PO daily on days 1-28.
ARM II: Patients receive erlotinib hydrochloride PO and quinacrine dihydrochloride PO daily (TID) on days, 1-7 and PO daily from days 8-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Dose Escalation Group) | Experimental | Drug: erlotinib hydrochloride, Drug: quinacrine dihydrochloride - Escalation dose, Other: laboratory biomarker analysis, Other: pharmacological studyErlotinib hydrochloride and quinacrine dihydrochloride. The first three or six patients will be entered in this part of the study. Then this part will end. |
| Arm II (Extension Group) | Experimental | Drug: erlotinib hydrochloride, Other: laboratory biomarker analysis, Other: pharmacological study, Drug: quinacrine dihydrochloride - Extension doseErlotinib hydrochloride and quinacrine dihydrochloride. The next 12 patients will enter into the second part of this study. |
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 incurable malignancy that is surgically unresectable locally advanced, recurrent, or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC). Patients with adenocarcinoma, squamous cell carcinoma, large cell carcinoma and sarcomatoid carcinoma will be eligible.
- Patients must have received at least one platinum-containing regimen for the treatment of advanced or metastatic disease (except for EGFR-mutant patients). Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen. NSCLC with documented EGFR mutation will be eligible after progression on an EGFR-TKI alone. NSCLC with other molecular targets, such as fusion gene involving the anaplastic lymphoma kinase (ALK) gene (such as echinoderm microtubule associated protein like 4 [EML4]-ALK) or ROS-1 will be eligible if they have progressed on targeted agents (ALK inhibitor) and chemotherapy or are not a candidate for chemotherapy. Adjuvant/neoadjuvant chemotherapy or chemoradiation is considered a line of therapy if < 12 months have elapsed between the last dose and the date of recurrence. Combined treatment with chemotherapy and radiation constitutes a single regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of ≥ 12 weeks, in the opinion of and as documented by the investigator
- Hemoglobin ≥ 9.0 g/dl (transfusion and/or growth factor support allowed)
Key exclusion criteria (14 listed)
- Patients with previous anti-cancer chemotherapy, immunotherapy or investigational agents ≤ 3 weeks prior to the first day of study defined treatment. NSCLC patients with EGFR mutation can enroll within 7 days of discontinuing EGFR-TKI. Palliative radiation < 1 week before the start of treatment (lesions subjected to radiotherapy may not be used as target lesions). Patients who receive gamma knife radiosurgery for brain metastases within 1 week prior to treatment start.
- Patients with unknown status of EGFR mutation (only for patients with adenocarcinoma histology)
- Patients that have had major surgery ≤ 3 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy, etc) ≤ 1 week prior to the first day of study defined treatment.
- History of cardiac disease: congestive heart failure defined as class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); previously diagnosed bradycardia or other cardiac arrhythmia defined as ≥ grade 2 according to NCI-CTCAE (version 4.0), or uncontrolled hypertension; myocardial infarction occurred within 6 months prior to study entry (myocardial infarction occurred > 6 months prior to study entry is permitted)
- Patients with clinically unstable central nervous system (CNS) metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by magnetic resonance imaging [MRI] or computed tomography [CT] scan within 4 weeks of the first day of study defined treatment and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications)
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 |
|---|---|---|
| erlotinib hydrochlorideAlso: CP-358,774, erlotinib, OSI-774Dose Escalation Group: Begins day 1: given 150mg daily, orally Extension Group: Begins Day 1: 150mg daily, orally | Drug | Arm I (Dose Escalation Group), Arm II (Extension Group) |
| quinacrine dihydrochloride - Escalation doseAlso: atabrine dihydrochloride, mepacrine dihydrochoride, SN 390Begins Day 8: Loading dose (first cycle only) 50mg three times daily for 7 days followed by 21 days of 50mg maintenance dose. Level -1: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg every other day for three weeks). Level 1 [starting dose]: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg daily for three weeks). Level 2: Loading dose (100mg three times daily for 7 days), maintenance dose (100mg every other day for three weeks). Level 3: Loading dose (150mg three times daily for 7 days), maintenance dose (200mg every other day for three weeks). Level 4: Loading dose (200mg three times daily for 7 days), maintenance dose (400mg every other day for three weeks). Subsequent patient cohort(s) will be enrolled depending on the safety and tolerability of subjects | Drug | Arm I (Dose Escalation Group) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (Dose Escalation Group), Arm II (Extension Group) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (Dose Escalation Group), Arm II (Extension Group) |
| quinacrine dihydrochloride - Extension doseAlso: atabrine dihydrochloride, mepacrine dihydrochoride, SN 390Participants will be treated at recommended dose from expansion group to confirm tolerability and evaluate early response | Drug | Arm II (Extension Group) |
Primary outcome
Maximum tolerated dose (MTD) of quinacrine dihydrochloride in combination of erlotinib hydrochloride determined by dose-limiting toxicities
Time frame: 28 days
Progression Free Survival (PFS)
Time frame: Date of randomization to the date of disease progression or the date of death, assessed up to 2 years
Estimated by Kaplan-Meier method and the difference between two treatment arms will be evaluated by log-rank test.
5 secondary outcomes
Pharmacokinetic parameters
Time frame: after 2 months (2 cycles)
Objective tumor response rate (ORR) (complete response and partial response) evaluated by revised Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Time frame: Up to 2 years
Disease stabilization rate (complete response, partial response and stable disease)
Time frame: Up to 2 years
Baseline expression of intracellular inhibitor of the nuclear factor kappa B (IkappaB) or NFkappaB gene signature in determining survival or response
Time frame: Baseline up to 2 years
Overall survival (OS)
Time frame: Date of randomization to the date of death, assessed up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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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.
Neelesh Sharma, MD, PhD principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive 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 1 study testing erlotinib hydrochloride, quinacrine dihydrochloride - Escalation dose and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by Neelesh Sharma MD PhD 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 16 inclusion and 14 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 31 Oct 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum tolerated dose (MTD) of quinacrine dihydrochloride in combination of erlotinib hydrochloride determined by dose-limiting toxicities (time frame: 28 days). 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 31 Oct 2016.