MelanomaPhase 1NCT00272415
A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma
A Phase 1 study testing INO-1001 and temozolomide in people with Melanoma, run by Genentech, Inc..
Trial summary
This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- INO-1001 and temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to not given
- 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
- Biopsy proven malignant melanoma with metastasis that is unresectable Stage III or Stage IV. Subjects with recurrent melanoma that is unresectable are also eligible
- Measurable indicator metastases
- Age 18 years or older
- ECOG status 0-2
- An interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea
- Hematocrit > 29%, ANC > 1500 cells/ul, platelets > 100,000 cells/ul
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- Serum creatinine within the laboratory's upper limit of normal
- Serum AST and ALT ≤ 1.5 x the laboratory's upper limit of normal
- Subject signed informed consent prior to subject entry
Who cannot join
- Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen.
- Subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment.
- Subjects previously treated with DTIC or TMZ
- Symptomatic central nervous metastases
- Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study.
- Confirmed diagnosis of hepatitis or HIV infection
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- Any medical, psychiatric, or social problem that might interfere with the performance, completion, and/or interpretation of the trial
- Patients who have had any surgery within two weeks prior to enrollment in this study, or who have not recovered from the side effects of this or any other therapy
- Patients unwilling to comply with the protocol or who in the judgment of the Principal Investigator are unable to abide by the rules of the protocol
- Subjects who have received a potent CYP3A4 inhibitor or inducer orally or parenterally within approximately 14 days prior to enrollment
- Subjects who have received amiodarone within 30 days of study drug administration
- History of hypersensitivity reaction to more than three (3) drugs or to mannitol
- Patients who have received any investigational study agent within 30 days of Day 1 of Cycle 1
About this study
Official title: A Phase Ib, Open-Label, Multicenter Trial of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate the Tolerability, Safety, and Pharmacokinetics in Subjects With Newly-Diagnosed or Recurrent Unresectable Stage III or Stage IV Melanoma
This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.
- Conditions
- Melanoma
- Being tested
- INO-1001, temozolomide
- Keywords
- INO4136g, inotek, Parp, Temodar
- Medical subject headings
- Melanoma, Deafness, Autosomal Recessive 53
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-1001Drug
Intravenous repeating dose
temozolomideDrug
Oral repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: INO-1001; Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ
Measured: Length of study
Pharmacokinetic (PK) profile of intravenous INO-1001
Measured: Length of study
Safety and tolerability of combined therapy with oral temozolomide (TMZ) and intravenous INO-1001
Measured: Length of study
Secondary outcomes (5)
Safety of repeat dosing
Measured: Length of study
Pharmacodynamic (PD) activity of intravenous INO-1001
Measured: Length of study
Response
Measured: Length of study
Progression-free survival
Measured: Length of study
Overall survival
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jennifer Low, M.D., Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272415
- Sponsor's protocol ID
- IPC-06-2004
- Other IDs
- INO4136g
- Status last verified
- Nov 2007
- First submitted
- 3 Jan 2006
- Last updated
- 11 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Multicenter Trial of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate the Tolerability, Safety, and Pharmacokinetics in Subjects With Newly-Diagnosed or Recurrent Unresectable Stage III or Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT00272415
- Acronym / sponsor ID
- IPC-06-2004
- Conditions
- Melanoma
- Keywords
- INO4136g, inotek, Parp, Temodar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- First posted
- 6 Jan 2006 (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 is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: INO-1001, Drug: temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biopsy proven malignant melanoma with metastasis that is unresectable Stage III or Stage IV. Subjects with recurrent melanoma that is unresectable are also eligible
- Measurable indicator metastases
- Age 18 years or older
- ECOG status 0-2
- An interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea
Key exclusion criteria (13 listed)
- Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen.
- Subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment.
- Subjects previously treated with DTIC or TMZ
- Symptomatic central nervous metastases
- Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study.
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 |
|---|---|---|
| INO-1001Intravenous repeating dose | Drug | 1 |
| temozolomideOral repeating dose | Drug | 1 |
Primary outcome
Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ
Time frame: Length of study
Pharmacokinetic (PK) profile of intravenous INO-1001
Time frame: Length of study
Safety and tolerability of combined therapy with oral temozolomide (TMZ) and intravenous INO-1001
Time frame: Length of study
5 secondary outcomes
Safety of repeat dosing
Time frame: Length of study
Pharmacodynamic (PD) activity of intravenous INO-1001
Time frame: Length of study
Response
Time frame: Length of study
Progression-free survival
Time frame: Length of study
Overall survival
Time frame: Length of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2009.
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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.
Jennifer Low, M.D., Ph.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INO-1001 and temozolomide in people with Melanoma, run by Genentech, Inc..
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 9 inclusion and 13 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 11 Mar 2009. 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 was stopped early. 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?
Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ (time frame: Length of study). 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 11 Mar 2009.