Advanced Nonhematological Malignancies
Conditions
Brief summary
Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies. This study will be the first to administer TAK-960 to humans. The patient population will consist of adults with a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential, or for which no standard treatment is available.
Interventions
DRUGTAK-960
TAK-960 administered orally once a day for 21-days of a 28-day treatment cycle. A 3 + 3 dose escalation scheme will be employed.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Male or female 18 years or older * Clinical laboratory values as specified in protocol * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically and/or cytologically confirmed diagnosis of metastatic, unresectable, advanced evaluable nonhematologic malignancy for which standard treatment is not available or no longer effective * Radiographically or clinically evaluable tumor * Suitable venous access for study-required blood sampling * Female patients who are postmenopausal, surgically sterile or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse * Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse * Voluntary written consent * Willing to undergo biopsy procedures (expansion phase only) * Weight at least 40 kg * Recovered from the reversible effects of prior antineoplastic therapy to Grade ≤ 1 or to patient's baseline values, excluding alopecia
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960 | up to 12 months | Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAK-960 Given orally (PO) for 21 days of a 28-day treatment cycle. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 30 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TAK-960 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 64.9 years STANDARD_DEVIATION 9.77 |
| Region of Enrollment Spain | 12 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 32 |
| serious Total, serious adverse events | 13 / 32 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960
Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
Time frame: up to 12 months
Population: Maximum tolerable dose (MTD) and recommended phase 2 dose (RP2D) of TAK-960 were not determined due to sponsor decision to discontinue the study for business reasons.