Malignant MelanomaPhase 1NCT01522664
A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
A Phase 1 study testing DEDN6526A in people with Malignant Melanoma, run by Genentech, Inc. at 6 sites in 2 countries.
Trial summary
This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of patients will receive escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- DEDN6526A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2012to Jun 2015
- 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
- Adult patients, >/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed metastatic melanoma (AJCC stage IV) or unresectable melanoma (AJCC Stage III)
- Prior failure of >/= 1 prior treatment regimens for metastatic or unresectable melanoma due to disease progression or unacceptable toxicity and for whom no standard therapy is available
- Measurable disease according to RECIST criteria
- Adequate bone marrow, liver and renal function
- Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception through the course of the study treatment and for 6 months after the last dose of study treatment
Who cannot join
- Treatment with cytotoxic or antibody based therapy within 21 days prior to first dose of study treatment, or with any other anti-cancer therapy within 5 half-lives of the therapy prior to first dose of study treatment
- Known active infection (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds)
- Current Grad >/= 2 toxicity (except alopecia or anorexia) from prior therapy
- Grade >/= 2 peripheral neuropathy
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapies (or recombinant antibody-related fusion proteins)
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Show all 11Show fewer
- Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- Evidence of significant uncontrolled concomitant disease or disorder
- Pregnant or lactating women
- Prior treatment with any other antibody-drug conjugate (ADC) compound containing monomethyl auristatin E (MMAE) for the treatment of melanoma
- Previous participation in a clinical trial within 30 days of the day of first study drug administration (Cycle 1, Day 1)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Study site
Detroit, Michigan, 48201
Study site
Los Angeles, California, 90025
Study site
Nashville, Tennessee, 37203
Study site
Sarasota, Florida, 34232
Australia2 sites
Study site
Camperdown, New South Wales, 2050
Study site
East Melbourne, Victoria, 3002
About this study
Official title: A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of patients will receive escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the absence of disease progression or unacceptable toxicity, patients may continue to receive DEDN6552A for up to 17 cycles (1 year).
- Conditions
- Malignant Melanoma
- Being tested
- DEDN6526A
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEDN6526ADrug
Multiple ascending doses
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Not described Receives: Drug: DEDN6526A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: assessed on an ongoing basis and up to 90 days following last dose of study treatment
Maximum tolerated dose/dose-limiting toxicities
Measured: approximately one year after study start
Determination of recommended Phase II dose
Measured: approximately 2 years
Secondary outcomes (3)
Pharmacokinetics: Area under the concentration-time curve
Measured: Pre-dose, 30 min. and 4, 24, 48 hours post-dose and Days 7, 10, 15, 17 Cycles 1-4, pre-dose and 30 min. post-dose Cycle 5 and every other cycle thereafter
Anti-therapeutic antibody (ATA) levels
Measured: Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose
Tumor response (tumor assessments according to RECIST criteria)
Measured: up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2015
- Study completionJun 2015
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 Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522664
- Sponsor's protocol ID
- GO27935
- Status last verified
- Nov 2016
- First submitted
- 20 Jan 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Sandhu S, McNeil CM, LoRusso P, Patel MR, Kabbarah O, Li C, Sanabria S, Flanagan WM, Yeh RF, Brunstein F, Nazzal D, Hicks R, Lemahieu V, Meng R, Hamid O, Infante JR. Phase I study of the anti-endothelin B receptor antibody-drug conjugate DEDN6526A in patients with metastatic or unresectable cutaneous, mucosal, or uveal melanoma. Invest New Drugs. 2020 Jun;38(3):844-854. doi: 10.1007/s10637-019-00832-1. Epub 2019 Aug 5.
PubMed 31385109
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
- ClinicalTrials.gov ID
- NCT01522664
- Acronym / sponsor ID
- GO27935
- Conditions
- Malignant Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Jan 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.
This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of patients will receive escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the absence of disease progression or unacceptable toxicity, patients may continue to receive DEDN6552A for up to 17 cycles (1 year).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Drug: DEDN6526A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients, >/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed metastatic melanoma (AJCC stage IV) or unresectable melanoma (AJCC Stage III)
- Prior failure of >/= 1 prior treatment regimens for metastatic or unresectable melanoma due to disease progression or unacceptable toxicity and for whom no standard therapy is available
- Measurable disease according to RECIST criteria
Key exclusion criteria (11 listed)
- Treatment with cytotoxic or antibody based therapy within 21 days prior to first dose of study treatment, or with any other anti-cancer therapy within 5 half-lives of the therapy prior to first dose of study treatment
- Known active infection (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds)
- Current Grad >/= 2 toxicity (except alopecia or anorexia) from prior therapy
- Grade >/= 2 peripheral neuropathy
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapies (or recombinant antibody-related fusion proteins)
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 |
|---|---|---|
| DEDN6526AMultiple ascending doses | Drug | Single group |
Primary outcome
Safety: Incidence of adverse events
Time frame: assessed on an ongoing basis and up to 90 days following last dose of study treatment
Maximum tolerated dose/dose-limiting toxicities
Time frame: approximately one year after study start
Determination of recommended Phase II dose
Time frame: approximately 2 years
3 secondary outcomes
Pharmacokinetics: Area under the concentration-time curve
Time frame: Pre-dose, 30 min. and 4, 24, 48 hours post-dose and Days 7, 10, 15, 17 Cycles 1-4, pre-dose and 30 min. post-dose Cycle 5 and every other cycle thereafter
Anti-therapeutic antibody (ATA) levels
Time frame: Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose
Tumor response (tumor assessments according to RECIST criteria)
Time frame: up to approximately 1 year
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 2 Nov 2016.
- Derived from this study: PubMed 31385109Sandhu S, McNeil CM, LoRusso P, Patel MR, Kabbarah O, Li C, Sanabria S, Flanagan WM, Yeh RF, Brunstein F, Nazzal D, Hicks R, Lemahieu V, Meng R, Hamid O, Infante JR. Phase I study of the anti-endothelin B receptor antibody-drug conjugate DEDN6526A in patients with metastatic or unresectable cutaneous, mucosal, or uveal melanoma. Invest New Drugs. 2020 Jun;38(3):844-854. doi: 10.1007/s10637-019-00832-1. Epub 2019 Aug 5.
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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.
Clinical Trials study director
Genentech, Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DEDN6526A in people with Malignant Melanoma, run by Genentech, Inc. at 6 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 7 inclusion and 11 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. 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?
Safety: Incidence of adverse events (time frame: assessed on an ongoing basis and up to 90 days following last dose of study treatment). The study lists 3 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 NCT01522664, 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 2 Nov 2016.