Phase 1 Completed N=46 Treatment

Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors

Cancer

Source: ClinicalTrials.gov NCT00705653 ↗

Enrolled (actual)

Serious AEs

54.4%

Results posted

Feb 2012

Primary outcomePrimary: Maximum Tolerated Dose (MTD) — 610 mg

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Tolerated Dose (MTD)	610	—
SECONDARY Preliminary Efficacy	30	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00705653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.