Malignant Solid TumorPhase 2NCT01457118
An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
A Phase 2 study testing NKTR-102 145 mg/m2, NKTR-102 120 mg/m2 and NKTR-102 95 mg/m2 in people with Malignant Solid Tumor, run by Nektar Therapeutics at 7 sites in 2 countries.
Trial summary
The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- NKTR-102 145 mg/m2, NKTR-102 120 mg/m2 and NKTR-102 95 mg/m2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2011to Nov 2017
- 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
- Received prior treatment with NKTR-102
- Free of disease progression since receiving NKTR-102
- Adequate bone marrow and organ function
- Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102
- Agree to use adequate contraception
Who cannot join
- Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study
- A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose < 70 mg/m2 upon entry into this study
- Pregnancy or lactation
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Investigator Site - Cleveland
Cleveland, Ohio, 44106
Investigator Site - Los Angeles
Los Angeles, California, 90033
Investigator Site - Minneapolis
Minneapolis, Minnesota, 55455
Investigator Site - San Francisco
San Francisco, California, 94143
Investigator Site - Whittier
Whittier, California, 90603
Belgium2 sites
Investigator Site - Bruxelles
Brussels
Investigator Site - Liege
Liège, 4000
About this study
Official title: An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102.
In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
- Conditions
- Malignant Solid Tumor
- Being tested
- NKTR-102 145 mg/m2, NKTR-102 120 mg/m2, NKTR-102 95 mg/m2, NKTR-102 50 mg/m2
- Keywords
- Open Label multicenter extension study advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR-102 145 mg/m2Drug
A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
NKTR-102 120 mg/m2Drug
A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
NKTR-102 95 mg/m2Drug
A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
NKTR-102 50 mg/m2Drug
A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| NKTR-102 | Experimental | Not described Receives: Drug: NKTR-102 145 mg/m2; Drug: NKTR-102 120 mg/m2; Drug: NKTR-102 95 mg/m2; Drug: NKTR-102 50 mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Exposure to NKTR-102
To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.
Measured: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Secondary outcomes (3)
Adverse Events
To evaluate the safety of continued exposure to NKTR-102.
Measured: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Disease Status
To observe disease status and survival status in subjects receiving NKTR-102.
Measured: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Efficacy of NKTR-102
To evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
Measured: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2017
- Study completionNov 2017
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 Malignant Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457118
- Sponsor's protocol ID
- 11-PIR-09
- Status last verified
- Jul 2021
- First submitted
- 19 Oct 2011
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
- ClinicalTrials.gov ID
- NCT01457118
- Acronym / sponsor ID
- 11-PIR-09
- Conditions
- Malignant Solid Tumor
- Keywords
- Open Label multicenter extension study advanced solid tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102.
In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NKTR-102 | Experimental | Drug: NKTR-102 145 mg/m2, Drug: NKTR-102 120 mg/m2, Drug: NKTR-102 95 mg/m2, Drug: NKTR-102 50 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Received prior treatment with NKTR-102
- Free of disease progression since receiving NKTR-102
- Adequate bone marrow and organ function
- Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt of their of last dose of NKTR-102
- Agree to use adequate contraception
Key exclusion criteria (3 listed)
- Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the prior study and before first dose of NKTR-102 in the extension study
- A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled to receive a dose < 70 mg/m2 upon entry into this study
- Pregnancy or lactation
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 |
|---|---|---|
| NKTR-102 145 mg/m2A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle. | Drug | NKTR-102 |
| NKTR-102 120 mg/m2A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle. | Drug | NKTR-102 |
| NKTR-102 95 mg/m2A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle. | Drug | NKTR-102 |
| NKTR-102 50 mg/m2A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle. | Drug | NKTR-102 |
Primary outcome
Length of Exposure to NKTR-102
Time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.
3 secondary outcomes
Adverse Events
Time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Disease Status
Time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Efficacy of NKTR-102
Time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- 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.
Study Director study director
Nektar Therapeutics
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NKTR-102 145 mg/m2, NKTR-102 120 mg/m2 and NKTR-102 95 mg/m2 in people with Malignant Solid Tumor, run by Nektar Therapeutics at 7 sites in 2 countries.
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 5 inclusion and 3 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 12 Jul 2021. 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, Belgium. 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 7 Jul 2021). 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?
Length of Exposure to NKTR-102 (time frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up). 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 12 Jul 2021.