Metastatic MelanomaPhase 1/2NCT00724841
A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma
A Phase 1/2 study testing Obatoclax Mesylate and Temozolomide in people with Metastatic Melanoma, run by Gemin X at 1 site in United States.
Trial summary
Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Obatoclax Mesylate and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2010
- Phase
- Phase 1/2
- 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 metastatic melanoma
- Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
- Normal organ and marrow function
- Willing to submit to blood sampling for planned PK/PD analyses
- Ability of understand and willingness to sign a written informed consent
Who cannot join
- No other investigational or commercial agents or therapies
- Prior exposure to GMX1777, GMX1778 or CHS828
- Patients with uncontrolled, intercurrent illness
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma
Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.
Read the detailed description
GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
- Conditions
- Metastatic Melanoma
- Being tested
- Obatoclax Mesylate, Temozolomide
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obatoclax MesylateDrug
Also called GMX1777
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
TemozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 40 mg/m2 GMX1777 with Temozolomide Receives: Drug: Obatoclax Mesylate; Drug: Temozolomide |
| 2 | Experimental | 50 mg/m2 GMX1777 with Temozolomide Receives: Drug: Obatoclax Mesylate; Drug: Temozolomide |
| 3 | Experimental | 62 mg/m2 GMX1777 with Temozolomide Receives: Drug: Obatoclax Mesylate; Drug: Temozolomide |
| 4 | Experimental | 80 mg/m2 GMX1777 with Temozolomide Receives: Drug: Obatoclax Mesylate; Drug: Temozolomide |
| 5 | Experimental | 100 mg/m2 GMX1777 with Temozolomide Receives: Drug: Obatoclax Mesylate; Drug: Temozolomide |
| 6 | Experimental | 125 mg/m2 GMX1777 with Temozolomide Receives: Drug: Obatoclax Mesylate; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
Measured: 2 years
Learn more about the side effects of taking GMX1777 in combination with temozolomide
Measured: Within the first 4 weeks
Determine the disease response to treatment with GMX1777 in combination with temozolomide
Measured: Within the first 8 weeks
Secondary outcomes (1)
Learn more about how the body processes GMX1777
Measured: Within the fisrt 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionAug 2010
Why it stopped: Study terminated prematurely due to financial contraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemin X
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Berger, MD, Study director, Gemin X, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724841
- Sponsor's protocol ID
- GEM303
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2008
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00724841
- Acronym / sponsor ID
- GEM303
- Conditions
- Metastatic Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to financial contraints.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Gemin XIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Jul 2008 (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.
Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.
Detailed description
GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Obatoclax Mesylate, Drug: Temozolomide40 mg/m2 GMX1777 with Temozolomide |
| 2 | Experimental | Drug: Obatoclax Mesylate, Drug: Temozolomide50 mg/m2 GMX1777 with Temozolomide |
| 3 | Experimental | Drug: Obatoclax Mesylate, Drug: Temozolomide62 mg/m2 GMX1777 with Temozolomide |
| 4 | Experimental | Drug: Obatoclax Mesylate, Drug: Temozolomide80 mg/m2 GMX1777 with Temozolomide |
| 5 | Experimental | Drug: Obatoclax Mesylate, Drug: Temozolomide100 mg/m2 GMX1777 with Temozolomide |
| 6 | Experimental | Drug: Obatoclax Mesylate, Drug: Temozolomide125 mg/m2 GMX1777 with Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed metastatic melanoma
- Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
- Normal organ and marrow function
- Willing to submit to blood sampling for planned PK/PD analyses
- Ability of understand and willingness to sign a written informed consent
Key exclusion criteria (4 listed)
- No other investigational or commercial agents or therapies
- Prior exposure to GMX1777, GMX1778 or CHS828
- Patients with uncontrolled, intercurrent illness
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Obatoclax MesylateAlso: GMX1777Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide | Drug | 1, 2, 3, 4, 5, 6 |
| Temozolomide | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
Time frame: 2 years
Learn more about the side effects of taking GMX1777 in combination with temozolomide
Time frame: Within the first 4 weeks
Determine the disease response to treatment with GMX1777 in combination with temozolomide
Time frame: Within the first 8 weeks
1 secondary outcome
Learn more about how the body processes GMX1777
Time frame: Within the fisrt 30 days
Results and safety
The study was stopped early (reason given: Study terminated prematurely due to financial contraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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.
Mark Berger, MD study director
Gemin X, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Obatoclax Mesylate and Temozolomide in people with Metastatic Melanoma, run by Gemin X 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 5 inclusion and 4 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 22 Jul 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 combined 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.
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: Study terminated prematurely due to financial contraints.). 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?
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide (time frame: 2 years). 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?
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 22 Jul 2016.