Advanced MelanomaPhase 1NCT00542893
A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine
A Phase 1 study testing Genasense® (G3139, oblimersen sodium), Genasense followed by DTIC; then DTIC alone and DTIC alone; then Genasense followed by DTIC in people with Advanced Melanoma, run by Genta Incorporated.
Trial summary
This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Genasense® (G3139, oblimersen sodium), Genasense followed by DTIC; then DTIC alone and DTIC alone; then Genasense followed by DTIC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2006to Sep 2007
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 12 weeks
- Adequate venous access
- Agreement to practice effective method of birth control
Who cannot join
- Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
- Significant medical disease
- Known hypersensitivity to phosphorothioate-containing oligonucleotides
- Known hypersensitivity to DTIC
- Pregnancy/Lactation
About this study
Official title: A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma
This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense
- Conditions
- Advanced Melanoma
- Being tested
- Genasense® (G3139, oblimersen sodium), Genasense followed by DTIC; then DTIC alone, DTIC alone; then Genasense followed by DTIC
- Keywords
- bcl-2, CFR, DTIC, ECOG, EMEA, MedDRA, NCI CTC, SAE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genasense® (G3139, oblimersen sodium)Drug
Genasense followed by DTIC; then DTIC aloneDrug
Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
DTIC alone; then Genasense followed by DTICDrug
Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Receives: Drug: Genasense® (G3139, oblimersen sodium); Drug: DTIC alone; then Genasense followed by DTIC |
| Group 2 | Experimental | Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2 Receives: Drug: Genasense® (G3139, oblimersen sodium); Drug: Genasense followed by DTIC; then DTIC alone |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startApr 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542893
- Sponsor's protocol ID
- GPK105
- Status last verified
- Mar 2012
- First submitted
- 10 Oct 2007
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00542893
- Acronym / sponsor ID
- GPK105
- Conditions
- Advanced Melanoma
- Keywords
- bcl-2, CFR, DTIC, ECOG, EMEA, MedDRA, NCI CTC, SAE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Oct 2007 (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 clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Genasense® (G3139, oblimersen sodium), Drug: DTIC alone; then Genasense followed by DTICCycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 |
| Group 2 | Experimental | Drug: Genasense® (G3139, oblimersen sodium), Drug: Genasense followed by DTIC; then DTIC aloneCycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 12 weeks
- Adequate venous access
- Agreement to practice effective method of birth control
Key exclusion criteria (5 listed)
- Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
- Significant medical disease
- Known hypersensitivity to phosphorothioate-containing oligonucleotides
- Known hypersensitivity to DTIC
- Pregnancy/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 |
|---|---|---|
| Genasense® (G3139, oblimersen sodium) | Drug | Group 1, Group 2 |
| Genasense followed by DTIC; then DTIC aloneCycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2 | Drug | Group 2 |
| DTIC alone; then Genasense followed by DTICCycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 | Drug | Group 1 |
Primary outcome
Not reported in the source record.
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 13 Mar 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genasense® (G3139, oblimersen sodium), Genasense followed by DTIC; then DTIC alone and DTIC alone; then Genasense followed by DTIC in people with Advanced Melanoma, run by Genta Incorporated.
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 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: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Mar 2012.