SNPMiner Trials by Shray Alag


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Report for Mutation G80A

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67

Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients with hormone refractory prostate cancer (HRPC), and has become the standard of care. The beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk (when measurable), reduction in prostate-specific antigen PSA, reduction in symptoms (particularly pain), or stabilization of disease. Clear reductions in tumor bulk or PSA may provide objective evidence of a treatment effect, and stabilization of disease may be just as clinically meaningful in patients who are actively progressing prior to starting therapy. Pemetrexed has shown a broad array of activity in many diseases that until now were thought to be non-responsive to chemotherapy in the second-line setting. This trial is designed to further assess the efficacy, safety, tolerability, and pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has progressed following one prior taxane-based chemotherapy regimen for HRPC.

NCT00216099 Prostate Cancer Drug: Pemetrexed Dietary Supplement: Folic Acid Dietary Supplement: Vitamin B12
MeSH: Prostatic Neoplasms
HPO: Prostate cancer Prostate neoplasm

CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.. RFC1 G80A Genotype. --- G80A ---

Samples for RFC1 G80A pharmacogenetic analysis were collected at screening. --- G80A ---

Primary Outcomes

Description: Best overall Prostate-Specific Antigen (PSA) response PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline

Measure: Best Overall PSA Response

Time: Start of treatment until disease progression/recurrence (for life)

Secondary Outcomes

Measure: Overall Survival

Time: From study enrollment until death (for life)

Description: Response Evaluation Criteria in Solid Tumors (RECIST). Objective overall response rate is defined as Complete Response (CR) + Partial Response (PR) Per RECIST: CR= Disappearance of all target and non-target lesions and normalization of tumor marker level PR= Disappearance of all target lesions and persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits OR at least a 30% decrease in the sum of the longest diameter, taking as reference the baseline sum longest diameter and disappearance of all non-target lesions or persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits

Measure: OBJECTIVE Overall Response Rate

Time: Start of treatment until disease progression/recurrence (for life)

Description: A clinical benefit is defined as an improvement for at least 3 consecutive weeks in at least one of the following parameters without any sustained worsening in any other: > 50% reduction in analgesic consumption or > 50% reduction in pain intensity or > 20 point gain in performance status.

Measure: Rate of Clinical Benefit

Time: Any time among evaluable subjects (for life)

Description: Safety and Tolerability was evaluated by reporting the percentage of patient who experienced grade 3 or 4 toxicities using Common Terminology Criteria for Adverse Events CTCAE v3.0 criteria. CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.

Measure: Safety and Tolerability

Time: 18 months

Description: Samples for RFC1 G80A pharmacogenetic analysis were collected at screening

Measure: RFC1 G80A Genotype

Time: Screening

Description: Progression per Response Evaluation Criteria in Solid Tumors (RECIST) or Prostate-Specific Antigen (PSA) Progression RECIST PD=at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions PSA progression=increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline *Note, upper confidence interval was not reached*

Measure: Time to Progression

Time: Study enrollment until progression per RECIST or PSA (for life)

Description: Serological Progression (sPD) - increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline

Measure: Time to Prostate-Specific Antigen (PSA)/Serological Progression

Time: From study enrollment to progression per PSA criteria (for life)


HPO Nodes


Prostate cancer
Genes 32
RNASEL TP53 RNF43 PTEN BARD1 RAD50 BRCA2 NBN BMPR1A BRCA1 NAB2 CDH1 RAD51C MXI1 PALB2 EPHB2 CHEK2 BRCA2 BRIP1 GREM1 MRE11 CHEK2 RAD51 ZFHX3 MAD1L1 TP53 RAD51D AR STAT6 PTEN APC KLF6