Trial Outcomes & Findings for Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients With Advanced Stage Rare Cancers, RARE 2 Trial (NCT NCT05142241)

Last Updated: 2026-08-12

Results Overview

The number of participants with an objective response to treatment, defined as a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Overall Response (OR) = CR + PR with CR indicating the disappearance of all target lesions and PR defined as a 30% or more decrease in the sum of the longest diameter of target lesions.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Restaging scans were carried out every two cycles (8 weeks) until the end of treatment, an average of 3.3 months.

Results posted on

2026-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Talazoparib, Temozolomide) Patients receive talazoparib PO QD on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An ECOG performance status of 0 indicates a participant is fully active and able to carry on all pre-disease performance without restriction; 1 indicates they are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work; and 2 indicates they are ambulatory and capable of all selfcare but unable to carry out any work activities (they are up and about more than 50% of waking hours).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Talazoparib, Temozolomide) n=14 Participants Patients receive talazoparib PO QD on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=1 Participants
Age, Categorical >=65 years	2 Participants n=1 Participants
Age, Continuous	53.9 Years STANDARD_DEVIATION 13.3 • n=1 Participants
Sex: Female, Male Female	12 Participants n=1 Participants
Sex: Female, Male Male	2 Participants n=1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1 Participants
Race (NIH/OMB) Asian	2 Participants n=1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1 Participants
Race (NIH/OMB) Black or African American	3 Participants n=1 Participants
Race (NIH/OMB) White	8 Participants n=1 Participants
Race (NIH/OMB) More than one race	0 Participants n=1 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1 Participants
Diagnosis: Tumor Type Uterine leiomyosarcoma	2 Participants n=1 Participants
Diagnosis: Tumor Type Salivary gland clear cell	1 Participants n=1 Participants
Diagnosis: Tumor Type Adrenocortical carcinoma	1 Participants n=1 Participants
Diagnosis: Tumor Type Angiosarcoma of the scalp	1 Participants n=1 Participants
Diagnosis: Tumor Type Uterine sarcoma	1 Participants n=1 Participants
Diagnosis: Tumor Type Malignant peripheral nerve sheath tumor	1 Participants n=1 Participants
Diagnosis: Tumor Type Cholangiocarcinoma	2 Participants n=1 Participants
Diagnosis: Tumor Type Adenoid cystic carcinoma of the parotid gland	1 Participants n=1 Participants
Diagnosis: Tumor Type Cancer of unknown primary	1 Participants n=1 Participants
Diagnosis: Tumor Type Small cell neuroendocrine tumor of the endometrium	1 Participants n=1 Participants
Diagnosis: Tumor Type Urothelial squamous cell carcinoma	1 Participants n=1 Participants
Diagnosis: Tumor Type Renal cell carcinoma	1 Participants n=1 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0	1 Participants n=1 Participants • An ECOG performance status of 0 indicates a participant is fully active and able to carry on all pre-disease performance without restriction; 1 indicates they are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work; and 2 indicates they are ambulatory and capable of all selfcare but unable to carry out any work activities (they are up and about more than 50% of waking hours).
Eastern Cooperative Oncology Group (ECOG) Performance Status 1	13 Participants n=1 Participants • An ECOG performance status of 0 indicates a participant is fully active and able to carry on all pre-disease performance without restriction; 1 indicates they are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work; and 2 indicates they are ambulatory and capable of all selfcare but unable to carry out any work activities (they are up and about more than 50% of waking hours).
Eastern Cooperative Oncology Group (ECOG) Performance Status 2	0 Participants n=1 Participants • An ECOG performance status of 0 indicates a participant is fully active and able to carry on all pre-disease performance without restriction; 1 indicates they are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work; and 2 indicates they are ambulatory and capable of all selfcare but unable to carry out any work activities (they are up and about more than 50% of waking hours).

PRIMARY outcome

Timeframe: Restaging scans were carried out every two cycles (8 weeks) until the end of treatment, an average of 3.3 months.

Outcome measures

Outcome measures
Measure	Treatment (Talazoparib, Temozolomide) n=14 Participants Patients receive talazoparib PO QD on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Objective Response	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At 6 months from treatment start date

The probability of participants remaining alive and progression-free at 6 months after the start of treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and is defined as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Treatment (Talazoparib, Temozolomide) n=14 Participants Patients receive talazoparib PO QD on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Estimated 6-month Progression-free Survival (PFS)	0.12 Probability Interval 0.02 to 0.7

Adverse Events

Treatment (Talazoparib, Temozolomide)

Serious events: 12 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Talazoparib, Temozolomide) n=14 participants at risk Patients receive talazoparib PO QD on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	71.4% 10/14 • Number of events 16 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Renal and urinary disorders Acute kidney injury	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Blood bilirubin increased	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Creatinine increased	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
General disorders Disease progression	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
General disorders Fatigue	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	7.1% 1/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hyponatremia	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Abdominal pain	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
General disorders Pain	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Lymphocyte count decreased	28.6% 4/14 • Number of events 4 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
General disorders Non-cardiac chest pain	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Platelet count decreased	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Cardiac disorders Sinus tachycardia	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations White blood count decreased	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.

Other adverse events

Other adverse events
Measure	Treatment (Talazoparib, Temozolomide) n=14 participants at risk Patients receive talazoparib PO QD on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Hypoalbuminemia	42.9% 6/14 • Number of events 9 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hypoglycemia	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hypomagnesemia	21.4% 3/14 • Number of events 6 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hyponatremia	50.0% 7/14 • Number of events 13 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hypophosphatemia	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Vascular disorders Hypotension	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Psychiatric disorders Insomnia	21.4% 3/14 • Number of events 3 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Abdominal pain	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Renal and urinary disorders Acute kidney disease	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Alanine aminotransferase increased	28.6% 4/14 • Number of events 4 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Alkaline phosphatase increased	50.0% 7/14 • Number of events 12 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Skin and subcutaneous tissue disorders Alopecia	21.4% 3/14 • Number of events 3 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Blood and lymphatic system disorders Anemia	92.9% 13/14 • Number of events 51 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Anorexia	42.9% 6/14 • Number of events 7 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Ascites	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Aspartate aminotransferase increased	42.9% 6/14 • Number of events 8 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • Number of events 3 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Blood bilirubin increased	21.4% 3/14 • Number of events 6 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Blood lactate dehydrogenase increased	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Eye disorders Blurred vision	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Infections and infestations Lip infection	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Lymphocyte count decreased	92.9% 13/14 • Number of events 32 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Musculoskeletal and connective tissue disorders Chest wall pain	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Colitis	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Constipation	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 2/14 • Number of events 3 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Infections and infestations COVID19	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Creatinine increased	7.1% 1/14 • Number of events 4 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Dental caries	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Diarrhea	14.3% 2/14 • Number of events 3 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Nervous system disorders Dizziness	28.6% 4/14 • Number of events 4 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Dyspepsia	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	28.6% 4/14 • Number of events 5 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Renal and urinary disorders Dysuria	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	28.6% 4/14 • Number of events 4 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Injury, poisoning and procedural complications Fall	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
General disorders Fatigue	50.0% 7/14 • Number of events 10 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Fecal incontinence	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
General disorders Fever	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Flatulence	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
General disorders Flu like symptoms	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Nervous system disorders Headache	28.6% 4/14 • Number of events 4 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Hemorrhoidal hemorrhage	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hypercalcemia	28.6% 4/14 • Number of events 6 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hyperglycemia	85.7% 12/14 • Number of events 19 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hyperkalemia	21.4% 3/14 • Number of events 3 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hyperphosphatemia	14.3% 2/14 • Number of events 3 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Vascular disorders Hypertension	50.0% 7/14 • Number of events 11 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hyperuricemia	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Skin and subcutaneous tissue disorders Nail discoloration	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Nausea	57.1% 8/14 • Number of events 10 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Neutrophil count decreased	92.9% 13/14 • Number of events 28 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Lung infection	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Musculoskeletal and connective tissue disorders Noncardiac chest pain	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
General disorders Pain	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 2/14 • Number of events 2 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Nervous system disorders Peripheral sensory neuropathy	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Platelet count decreased	92.9% 13/14 • Number of events 49 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Rectal hemorrhage	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Renal and urinary disorders Renal and urinary disorders - Other, specify	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Cardiac disorders Sinus tachycardia	35.7% 5/14 • Number of events 6 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Infections and infestations Skin infection	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Stomach pain	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Nervous system disorders Tumor pain	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Gastrointestinal disorders Vomiting	28.6% 4/14 • Number of events 6 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Weight loss	21.4% 3/14 • Number of events 5 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations White blood count decreased	78.6% 11/14 • Number of events 34 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Respiratory, thoracic and mediastinal disorders Productive cough	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Investigations Activated partial thromboplastin time prolonged	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Metabolism and nutrition disorders Hypocalcemia	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissues disorders; other	7.1% 1/14 • Number of events 1 • From the date the treatment consent was signed to the date off study, an average of 4.0 months.

Additional Information

Dr. Alice P. Chen

National Cancer Institute

Phone: 240-781-3274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60