Solid Tumors Clinical Trial
Official title:
Registry Study for Personalized Cancer Therapy
Verified date | July 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Objectives:
Primary Objectives:
To evaluate the anti-cancer activity of commercially available, targeted anti-cancer
therapies used off-label for treatment in patients with advanced solid cancer with known
genomic aberrations.
Secondary Objectives:
To determine outcomes of patients who were treated with matched targeted anti-cancer
therapies based on known genomic aberrations.
To obtain treatment related adverse events in patients with advanced solid tumor who were
treated with off -label targeted therapies.
To determine co-genomic aberrations that may contribute to treatment response or resistance
mechanisms.
To determine feasibility of detecting the genomic alterations in plasma, and the genomic
evolution of circulating biomarkers.
Status | Completed |
Enrollment | 5 |
Est. completion date | July 10, 2020 |
Est. primary completion date | July 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with advanced or metastatic cancer that is refractory to standard therapy or that has relapsed after standard therapy or has no standard therapy that increases survival by at least three months. 2. Patients with a potentially actionable genomic alteration. 3. All prior treatment-related toxicities must be resolved to CTCAE (Version 4.0) < or = Grade 2 (except alopecia) at the time of screening. 4. Patients willing to sign informed consent. 5. Patients under the age of 18 years old are allowed as long as the safety profile of the drug is established in the pediatric population. Exclusion Criteria: 1. Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator. 2. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to planned treatment drug. 3. Rapidly progressing leptomeningeal or brain metastases or spinal cord compression. 4. Clinical trial (including targeted and/or non-targeted) other than registry study is available; patient is willing and eligible to enroll in such trial. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor Response | Evaluation of tumor: the same imaging technique used during the initial evaluation or more sophisticated studies performed once after 2 cycles. Patients with measurable disease assessed by standard RECIST (Version 1.1). |
8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00750841 -
Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours
|
Phase 1 | |
Withdrawn |
NCT05419817 -
Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System
|
Phase 2 | |
Completed |
NCT02828930 -
A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)
|
Phase 1 | |
Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
Completed |
NCT03258515 -
A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT03225105 -
M3541 in Combination With Radiotherapy in Solid Tumors
|
Phase 1 | |
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT01878890 -
Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.
|
Phase 1 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT03634982 -
Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04685226 -
A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT06036121 -
A Study of ADRX-0706 in Select Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
Completed |
NCT01528046 -
Metformin in Children With Relapsed or Refractory Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05325866 -
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
|
Phase 1/Phase 2 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT02759640 -
A Phase I Trial of HS-10241 in Solid Tumors
|
Phase 1 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Withdrawn |
NCT01940601 -
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors
|
Phase 2 |