Safety Study of Sterile Compound c31510 for Injection to Subjects With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01251562|
Recruitment Status : Suspended (Interim Analysis)
First Posted : December 2, 2010
Last Update Posted : May 16, 2014
The primary objective of this clinical study is as follows:
• To determine the MTD and to assess the safety and tolerability of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors
The secondary objective of this study is as follows:
• To evaluate plasma PK and estimate renal elimination of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors
The exploratory objectives of this study are as follows:
- To evaluate the pharmacodynamic correlates of C31510 activity in plasma and peripheral blood cells
- To radiographically evaluate the effects of C31510 on tumors. In selected subjects, the effects on vascular permeability will be assessed by digital contrast enhanced (DCE)-magnetic resonance imaging (MRI)
- To evaluate tumor response (preliminary antitumor activity) after repeat administration of C31510
- Long-term safety and tolerability of C31510 after repeat administration
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Sterile Compound c31510 for Injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile Compound c31510 for Injection Administered Intravenously to Subjects With Solid Tumors|
|Study Start Date :||January 2011|
|Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||May 2014|
|Experimental: intravenous injection||
Drug: Sterile Compound c31510 for Injection
During the treatment period, subjects in each initial dose level cohort will have a single 4-hour IV infusion of C31510 at the assigned dose level of their particular cohort, three times per week for 26 days (on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26) followed by a 28-day follow up period that will be counted from the first dose given on Day 1. In the absence of unacceptable toxicity or disease progression during the treatment period, those subjects may receive similar 28-day repeat treatment cycles of 3 times per week for up to 1 year, at the discretion of the investigator.
- Tumor Assessment [ Time Frame: at baseline and then once every two treatment cycles of 28 days (2 months) thereafter in the absence of clinical rapid progression of disease. ]
Tumors will be assessed by standard methods ex. computerized tomography (CT), MRI etc; at baseline and then once every two treatment cycles of 28 days (2 months) thereafter in the absence of clinical rapid progression of disease.
Assessment of tumor vascularity (using DCE-MRI) for at least 6 subjects who received C31510 at the MTD, will be done within 24 hours pre-dose and post-dose.
- blood samples taken for plasma pharmacokinetics (PK) evaluation [ Time Frame: Blood samples collected at pre-dose, post-start of infusion at 0.5, 1, 2, 3.75 (15 min prior to end of infusion), 4.083 (5 min after the end of the infusion) 4.5, 6, 8, 10, and 24 hrs. after the start of the infusion ]
samples are taken to evaluate plasma pharmacokinetics (PK) and estimate renal elimination of C31510 administered as a single IV infusion in subjects with solid tumors
PK will be collected during Day 1 of the first month of each cohort at the following timepoints: pre-dose, post-start of infusion at 0.5, 1, 2, 3.75 (15 min prior to end of infusion), 4.083 (5 min after end of the infusion) 4.5, 6, 8, 10, and 24 hrs. after start of the infusion
Additional PK will be done at pre-dose time and at 24 hours post the dose of Day 3, and on Day 28.
- blood samples taken for plasma pharmacodynamics evaluation [ Time Frame: Pharmacodynamic blood samples will be collected pre-dose and at 4 and 24 hours post dose after start of the infusion of Day 1 of each treatment cycle. ]blood samples are taken to evaluate the pharmacodynamic correlation of C31510 activity in plasma and peripheral blood cells
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251562
|United States, California|
|Sarcoma Oncology Center|
|Santa Monica, California, United States, 90403|