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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of BG-C477 in Participants With Advanced Solid Tumors

NCT06596473

Advanced Solid Tumors

RECRUITING PHASE1

A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors

NCT01760525

Solid Tumor With p53 Wild Type Status

COMPLETED PHASE1

Study of SGR-3515 In Participants With Advanced Solid Tumors.

NCT06463340

Advanced Solid Tumor

RECRUITING PHASE1

A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

NCT05028478

Locally Advanced Solid Tumor Metastatic Solid Tumor Hematologic Malignancies

UNKNOWN PHASE1/PHASE2

A Study of AMG 337 in Subjects With Advanced Solid Tumors

NCT01253707

Advanced Malignancy Advanced Solid Tumors Cancer +3 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PG-11047

Group Type EXPERIMENTAL

PG-11047

Intervention Type DRUG

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PG-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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No