Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I, Dose-Escalation, Safety and Tolerability Study of COH29 in Patients With Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists
Verified date | January 2024 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I trial studies the side effects and best dose of RNR Inhibitor City of Hope 29 (COH29) in treating patients with solid tumors that are refractory to standard therapy or for which no standard therapy exists. COH29 may inhibit an enzyme called ribonucleotide reductase and may interfere with the ability of tumor cells to grow.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | December 31, 2024 |
Est. primary completion date | November 23, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients must have the ability to understand and the willingness to sign a written informed consent - Life expectancy of greater than 3 months by physician assessment - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) solid tumor that is metastatic, unresectable, progressive, or recurrent, and for which standard curative or palliative measures do not exist or are no longer effective - Patients must have measurable or evaluable disease - Patients must not have received prior chemotherapy or radiation for < 4 weeks prior to start of study treatment - Patients may be entered if they have received prior radiation therapy involving =< 30% of the bone marrow; any prior radiation therapy must have been administered >= 4 weeks prior to start of study treatment and the patient must be recovered from the acute toxic effects of the treatment prior to start of study treatment - Patients may be enrolled with a history of treated brain metastases that are clinically stable for >= 4 weeks prior to start of study treatment - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; women of child-bearing age will undergo urine pregnancy testing prior to study enrollment; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately - Active breast-feeding is also not allowed on study enrollment - Leukocytes >= 3,000 cells/µL - Absolute neutrophil count >= 1,500 cells/µL - Platelets >= 100, 000 cells/µL - Total bilirubin =< 1.5 times the upper limit of normal (ULN) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN; AST/ALT =< 5 x ULN if liver metastasis is present - Serum creatinine =< 1.5 mg/dL or a measured creatinine clearance >= 50 mL/min - Prothrombin time (PT)/international normalized ratio (INR)/ activated partial thromboplastin time (aPTT) =< 1.5 x ULN - Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) Exclusion Criteria: - Patients may not be receiving any other investigational agents; use of over-the-counter herbal medications will also be excluded - Patients with uncontrolled undercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements - Patients unable or unwilling to swallow pills - Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease or heart block, or uncontrolled congestive heart failure - Patients with a history of noninfectious pneumonitis will be excluded during the dose-escalation phase of the trial - Patients, who in the opinion of the investigator and another independent party, may not be able to adhere to the safety monitoring requirements of the study |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of RNR inhibitor COH29, defined as the dose level with no more than 1 dose limiting toxicity (DLT) in the first 6 patients at a dose level below a dose level with DLT in 2 of 6 patients, graded according to CTCAE version 4.0 | Day 28 | ||
Secondary | Changes in plasma biomarker expression levels | Descriptive statistics and graphical displays will be used to summarize levels of plasma CK18, dNTP pools, gamma-H2AX, and PAR expression at each time point and evaluate changes between pre- and post-treatment measurements. A paired t-test will be used to determine if there is a statistically significant change. | Baseline to up to 30 days after completion of study treatment | |
Secondary | Pharmacokinetics of RNR inhibitor COH29 | COH29 levels in plasma will be quantitated using a validated High Performance Liquid Chromatography (HPLC) tandem mass spectrometry (LC-MS/MS) method. Summary statistics of the pharmacokinetic parameters for the population will be derived from the parameters obtained in individual patients. | Pre-dose and 15 minutes, 30 minutes, 1, 2 , 3, 4, 6, 8, 24, and 168 hours post the day 1, course 1 dose | |
Secondary | Toxicities according to the National Cancer Institute (NCI) CTCAE v 4.0 | Toxicities will be tabulated by type and grade. | Up to 30 days after completion of study treatment | |
Secondary | Response rate | Response rate will be estimated in the overall population and 95% exact confidence intervals will be estimated. | Up to 30 days after completion of study treatment | |
Secondary | RR protein levels as assessed by automated quantitative analysis (AQUA) | Will be summarized descriptively using means, median, standard deviation and range. | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
Completed |
NCT00255658 -
Sorafenib and Temsirolimus in Treating Patients With Unresectable or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT00121277 -
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |