Non Small Cell Lung Cancer (NSCLC)Phase 2NCT01741155
Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)
A Phase 2 study testing SPI-1620 and Docetaxel in people with Non Small Cell Lung Cancer (NSCLC), run by Spectrum Pharmaceuticals, Inc at 5 sites in United States.
Trial summary
The purpose of this study is to estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC and to determine the safety of SPI-1620 when administered in combination with docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- SPI-1620 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2013to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC that has failed one prior platinum-containing chemotherapy
- Measurable disease as per RECIST v. 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Adequate bone marrow, liver and renal function
Who cannot join
- More than one prior chemotherapy regimen for metastatic NSCLC
- Known, uncontrolled central nervous system (CNS) metastases
- Significant circulatory disorders in the past 6 mo.
- Concomitant treatment with phosphodiesterase inhibitors
- Uncontrolled orthostatic hypotension, asthma or chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Tennessee Oncology PLLC
Chattanooga, Tennessee, 37404
Oncology Hematology Care Inc.
Cincinnati, Ohio, 45242
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Tennessee Oncology
Nashville, Tennessee, 37203
Virginia Cancer Institute
Richmond, Virginia, 23230
About this study
Official title: A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy
The purpose of this study is to estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC and to determine the safety of SPI-1620 when administered in combination with docetaxel.
Read the detailed description
This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part will be initiated.
In the Randomized Part approximately 200 patients (100 per arm) will be randomized to receive SPI-1620 plus docetaxel or docetaxel alone.
In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or intolerable toxicity.
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Being tested
- SPI-1620, Docetaxel
- 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.
SPI-1620Drug
SPI-1620 11 μg/m2 administered intravenously over one minute.
DocetaxelDrug
Also called Taxotere
Docetaxel: 75 mg/m2 administered as IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Part: SPI-1620 & Docetaxel | Experimental | Patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity. Receives: Drug: SPI-1620; Drug: Docetaxel |
| Randomized Part: SPI-1620 & Docetaxel | Experimental | Patients will receive 11 μg/m^2 of SPI-1620 intravenous (IV) followed by docetaxel 75 mg/m^2 IV administered in 3-week cycles until progression or intolerable toxicity. Receives: Drug: SPI-1620; Drug: Docetaxel |
| Randomized Part: Docetaxel | Active comparator | Patients will receive 75 mg/m^2 docetaxel in 3-week cycles until progression or intolerable toxicity. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR) of SPI-1620
To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC
Measured: Up to 2 years
Secondary outcomes (4)
Duration of Response (DoR)
only in Randomized Part.
Measured: Up to 12 weeks
Progression-free survival(PFS)
only in Randomized Part
Measured: 2 years from the start of study treatment
Overall survival (OS)
Measured: 2 years from the start of study treatment
Safety of SPI-1620
Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed.
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 posted4 Dec 2012 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: The study did not meet efficacy end point and did not enroll patients in the randomized phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer (NSCLC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741155
- Sponsor's protocol ID
- SPI-1620-12-201
- Status last verified
- Oct 2021
- First submitted
- 27 Nov 2012
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT01741155
- Acronym / sponsor ID
- SPI-1620-12-201
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study did not meet efficacy end point and did not enroll patients in the randomized phase.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- May 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Dec 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.
The purpose of this study is to estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC and to determine the safety of SPI-1620 when administered in combination with docetaxel.
Detailed description
This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part will be initiated.
In the Randomized Part approximately 200 patients (100 per arm) will be randomized to receive SPI-1620 plus docetaxel or docetaxel alone.
In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Arm Part: SPI-1620 & Docetaxel | Experimental | Drug: SPI-1620, Drug: DocetaxelPatients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity. |
| Randomized Part: SPI-1620 & Docetaxel | Experimental | Drug: SPI-1620, Drug: DocetaxelPatients will receive 11 μg/m^2 of SPI-1620 intravenous (IV) followed by docetaxel 75 mg/m^2 IV administered in 3-week cycles until progression or intolerable toxicity. |
| Randomized Part: Docetaxel | Active comparator | Drug: DocetaxelPatients will receive 75 mg/m^2 docetaxel in 3-week cycles until progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC that has failed one prior platinum-containing chemotherapy
- Measurable disease as per RECIST v. 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Adequate bone marrow, liver and renal function
Key exclusion criteria (5 listed)
- More than one prior chemotherapy regimen for metastatic NSCLC
- Known, uncontrolled central nervous system (CNS) metastases
- Significant circulatory disorders in the past 6 mo.
- Concomitant treatment with phosphodiesterase inhibitors
- Uncontrolled orthostatic hypotension, asthma or chronic obstructive pulmonary disease (COPD)
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 |
|---|---|---|
| SPI-1620SPI-1620 11 μg/m2 administered intravenously over one minute. | Drug | Randomized Part: SPI-1620 & Docetaxel, Single Arm Part: SPI-1620 & Docetaxel |
| DocetaxelAlso: TaxotereDocetaxel: 75 mg/m2 administered as IV infusion. | Drug | Randomized Part: Docetaxel, Randomized Part: SPI-1620 & Docetaxel, Single Arm Part: SPI-1620 & Docetaxel |
Primary outcome
Objective Response Rate(ORR) of SPI-1620
Time frame: Up to 2 years
To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC
4 secondary outcomes
Duration of Response (DoR)
Time frame: Up to 12 weeks
Progression-free survival(PFS)
Time frame: 2 years from the start of study treatment
Overall survival (OS)
Time frame: 2 years from the start of study treatment
Safety of SPI-1620
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: The study did not meet efficacy end point and did not enroll patients in the randomized phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 SPI-1620 and Docetaxel in people with Non Small Cell Lung Cancer (NSCLC), run by Spectrum Pharmaceuticals, Inc 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 4 inclusion and 5 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 13 Oct 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study did not meet efficacy end point and did not enroll patients in the randomized phase.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) of SPI-1620 (time frame: Up to 2 years). 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 13 Oct 2021.