Cancer
Conditions
Keywords
cancer, advanced cancer, solid tumors, CGC-11047, PG-11047
Brief summary
This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investigated in this study and the maximum tolerated dose of the drug will be established.
Detailed description
This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is 2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor response will be performed every 2 cycles.
Interventions
DRUGPG-11047
PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. A treatment cycle will be defined as 4 weeks of therapy. The planned minimum treatment schedule is 2 cycles of PG-11047 treatment (8 weeks).
Sponsors
Progen Pharmaceuticals
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
* non-hematological malignancy where standard therapeutic measures do not exist or no longer effective. * ECOG - 0-2. * Life expectancy \> 3 months.
Exclusion criteria
* chemotherapy or radiotherapy within 4 weeks prior to entering the study. * previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell transplantation. * primary brain tumors or active brain metastases * history of significant or symptomatic cardiac arrhythmia, prior myocardial infarction or evidence of a current significant ventricular conduction abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | The MTD had to occur during cycle 1 of treatment | The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT). Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary Efficacy | For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate. | As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PG-11047 Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | PG-11047 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants |
| Age Continuous | 61.2 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 46 / 46 |
| serious Total, serious adverse events | 25 / 46 |
Outcome results
Primary
Maximum Tolerated Dose (MTD)
The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT). Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047.
Time frame: The MTD had to occur during cycle 1 of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PG-11047 | Maximum Tolerated Dose (MTD) | 610 mg |
Secondary
Preliminary Efficacy
As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.
Population: Patients with non-missing overall response
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PG-11047 | Preliminary Efficacy | 30 percentage (of participants) |