Advanced Lung CancerPhase 1NCT01579994
Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
A Phase 1 study testing Ganetespib (STA-9090) and crizotinib in people with Advanced Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard dose of crizotinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- Ganetespib (STA-9090) and crizotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Apr 2012to 28 Dec 2020
- 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
- Histologically or cytologically proven diagnosis confirmed at MSKCC of advanced lung adenocarcinoma that is locally advanced or metastatic (stage III/IV).
- Positive for translocation or inversion events involving the ALK gene locus as determined standard methods (including but not limited to by FISH and IHC testing).
- No prior treatment with crizotinib, but they may have received prior cytotoxic chemotherapy.
- Age ≥ 18 years.
- Measurable (RECIST 1.1) indicator lesion not previously irradiated.
- Karnofsky Performance Status ≥ 70%
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- Able to take oral medications
- A negative serum pregnancy test obtained within two weeks prior to administration of the experimental agents in all pre-menopausal women (last menstrual period ≤ 24 months ago).
- All women of child bearing potential (WOCBP) and sexually active men must agree to use adequate methods of birth control throughout the study which include use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy and/or tubal libation and total abstinence.
Who cannot join
- Prior crizotinib therapy
- Inadequate recovery from any toxicity related to prior treatment (to Grade 1 or baseline).
- Inadequate hematologic function defined as:
- Absolute neutrophil count (ANC) < 1,000 cells/mm³.
- Platelet count < 75,000/mm³
- Hemoglobin < 9.0g/dL.
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- Inadequate hepatic function defined by:
- AST and/or ALT > 3x upper limited of normal (ULN).
- Total bilirubin > 2x ULN.
- Alkaline phosphatase > 3x ULN.
- Patients with hepatic metastases may have ALT/AST ≤ 5x ULN.
- Patients with hepatic and/or bone metastases may have an AP ≤ 5x ULN.
- Inadequate renal function defined by serum creatinine > 2x ULN Uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs/symptoms related to infection without improvement, despite appropriate anti-infective medications or other treatment).
- Patients with clinically active brain metastasis (requiring therapy with steroids or radiation therapy). Patients with clinically stable brain metastases (previously treated or untreated) for two weeks are eligible.
- Significant cardiac disease (e.g. New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias).
- Previously or current malignancies at other sites within the last 2 years, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, or prostate cancer that does not require active treatment per National Comprehensive Cancer Network (NCCN) guidelines.
- Women who are pregnant or lactating
- Use of drugs or food that are known potent CYP3A4 inhibitors (see Appendix C)
- Use of drugs that are known potent CYP3A4 inducers (see Appendix D)
- Any other condition that, in the opinion of the Investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, 10591
About this study
Official title: A Phase I Study of Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard dose of crizotinib. If this dose does not cause significant side effects, it will be increased as new patients take part in the study. The study will only be open at Memorial Sloan Kettering Cancer Center.
- Conditions
- Advanced Lung Cancer
- Being tested
- Ganetespib (STA-9090) and crizotinib
- Keywords
- adenocarcinoma, Lung, Metastatic, Crizotinib, Ganetespib, STA-9090, ALK Positive Lung Cancers, 12-015
- Medical subject headings
- Adenocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganetespib (STA-9090) and crizotinibDrug
Ganetespib (STA-9090) is given intravenously (days 1 and 8 of a 21 day cycle). Crizotinib will be given at the FDA approved dose of 250mg orally twice daily in a continuous fashion.
| Study group | Role | What they receive |
|---|---|---|
| Ganetespib (STA-9090) and crizotinib | Experimental | This protocol is a phase I single arm, open label, single institution study of crizotinib and ganetespib (STA-9090) in patients with ALK+ advanced NSCLC who are crizotinib naïve. Receives: Drug: Ganetespib (STA-9090) and crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
A standard 3+3 design will be used to find the maximum tolerated dose (MTD). Patients who withdraw before completing a full cycle will be replaced. There will be three set dose levels, using the approved dose of crizotinib, with 50%, 75% and 100% of the ganetespib (STA-9090) maximum tolerated dose of 200 mg/m2.
Measured: 1 year
efficacy
patients with ALK rearranged NSCLC at delaying acquired resistance to crizotinib by measuring progression free survival
Measured: 1 year
Secondary outcomes (2)
overall survival (OS)
as defined by time from study entry to death due to any cause and overall response rate (RR), as defined by the combination of complete responses and partial responses according to RECIST 1.1
Measured: 1 year
safety profile
Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study start16 Apr 2012
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregrory Riely, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579994
- Sponsor's protocol ID
- 12-015
- Status last verified
- Dec 2020
- First submitted
- 16 Apr 2012
- Last updated
- 30 Dec 2020
- Results posted
- No
Publications
Wong KM, Noonan S, O'Bryant C, Jimeno A. Alectinib for the treatment of ALK-positive stage IV non-small cell lung cancer. Drugs Today (Barc). 2015 Mar;51(3):161-70. doi: 10.1358/dot.2015.51.3.2294597.
PubMed 25876560
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
- ClinicalTrials.gov ID
- NCT01579994
- Acronym / sponsor ID
- 12-015
- Conditions
- Advanced Lung Cancer
- Keywords
- adenocarcinoma, Lung, Metastatic, Crizotinib, Ganetespib, STA-9090, ALK Positive Lung Cancers, 12-015
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Apr 2012 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 18 Apr 2012 (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.
About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard dose of crizotinib. If this dose does not cause significant side effects, it will be increased as new patients take part in the study. The study will only be open at Memorial Sloan Kettering Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ganetespib (STA-9090) and crizotinib | Experimental | Drug: Ganetespib (STA-9090) and crizotinibThis protocol is a phase I single arm, open label, single institution study of crizotinib and ganetespib (STA-9090) in patients with ALK+ advanced NSCLC who are crizotinib naïve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically proven diagnosis confirmed at MSKCC of advanced lung adenocarcinoma that is locally advanced or metastatic (stage III/IV).
- Positive for translocation or inversion events involving the ALK gene locus as determined standard methods (including but not limited to by FISH and IHC testing).
- No prior treatment with crizotinib, but they may have received prior cytotoxic chemotherapy.
- Age ≥ 18 years.
- Measurable (RECIST 1.1) indicator lesion not previously irradiated.
Key exclusion criteria (20 listed)
- Prior crizotinib therapy
- Inadequate recovery from any toxicity related to prior treatment (to Grade 1 or baseline).
- Inadequate hematologic function defined as:
- AST and/or ALT > 3x upper limited of normal (ULN).
- Total bilirubin > 2x ULN.
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 |
|---|---|---|
| Ganetespib (STA-9090) and crizotinibGanetespib (STA-9090) is given intravenously (days 1 and 8 of a 21 day cycle). Crizotinib will be given at the FDA approved dose of 250mg orally twice daily in a continuous fashion. | Drug | Ganetespib (STA-9090) and crizotinib |
Primary outcome
maximum tolerated dose
Time frame: 1 year
A standard 3+3 design will be used to find the maximum tolerated dose (MTD). Patients who withdraw before completing a full cycle will be replaced. There will be three set dose levels, using the approved dose of crizotinib, with 50%, 75% and 100% of the ganetespib (STA-9090) maximum tolerated dose of 200 mg/m2.
efficacy
Time frame: 1 year
patients with ALK rearranged NSCLC at delaying acquired resistance to crizotinib by measuring progression free survival
2 secondary outcomes
overall survival (OS)
Time frame: 1 year
safety profile
Time frame: 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 30 Dec 2020.
- Derived from this study: PubMed 25876560Wong KM, Noonan S, O'Bryant C, Jimeno A. Alectinib for the treatment of ALK-positive stage IV non-small cell lung cancer. Drugs Today (Barc). 2015 Mar;51(3):161-70. doi: 10.1358/dot.2015.51.3.2294597.
- 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.
Gregrory Riely, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ganetespib (STA-9090) and crizotinib in people with Advanced Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 5 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 9 inclusion and 20 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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT01579994, 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 30 Dec 2020.