Clinical trial NCT00272415: A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Melanoma
Keywords: INO4136g
inotek
Parp
Temodar
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ
timeFrame: Length of study
measure: Pharmacokinetic (PK) profile of intravenous INO-1001
timeFrame: Length of study
measure: Safety and tolerability of combined therapy with oral temozolomide (TMZ) and intravenous INO-1001
timeFrame: Length of study
Secondary outcomes:
measure: Safety of repeat dosing
timeFrame: Length of study
measure: Pharmacodynamic (PD) activity of intravenous INO-1001
timeFrame: Length of study
measure: Response
timeFrame: Length of study
measure: Progression-free survival
timeFrame: Length of study
measure: Overall survival
timeFrame: Length of study
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Jennifer Low, M.D., Ph.D.
role: STUDY_DIRECTOR
References: