Trial Search Results

G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

The study drug, G1T48 is an oral SERD that may be administered at doses for higher relative exposure, w/ less discomfort and potentially superior clinical benefit than the currently approved injectable SERD

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

G1 Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: G1T48
  • Drug: Palbociclib

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - For Part 1, postmenopausal women only

   - For Parts 2 and 3, any menopausal status

   - Confirmed diagnosis of ER-positive, HER2-negative advanced breast cancer, not amenable
   to curative therapy

   - For Part 1, prior treatment with less than 4 prior lines of chemotherapy

   - For Part 2, prior treatment with less than 2 prior line of chemotherapy

   - For Part 3, prior treatment with no more than 1 prior line of chemotherapy

   - For Parts 1 and 2, prior treatment with less than 4 prior endocrine therapies for
   metastatic breast cancer

   - For Part 3, prior treatment with no more than 1 prior line of endocrine therapies for
   metastatic breast cancer

   - For Parts 1 and 2, patients must satisfy 1 of the following criteria for prior
   therapy:

      - Progressed during treatment or within 12 months of completion of adjuvant therapy
      with an aromatase inhibitor

      - Progressed after the end of prior aromatase inhibitor therapy for
      advanced/metastatic breast cancer

   - For Part 3, patients must satisfy 1 of the following criteria for prior therapy:

      - Received ≥ 24 months of endocrine therapy in the adjuvant setting prior to
      recurrence or progression

      - Received ≥ 6 months of endocrine therapy in the advanced/metastatic setting prior
      to progression

   - For Part 1, evaluable or measurable disease

   - For Parts 2 and 3, evaluable (approximately 25%) or measurable disease (approximately
   75%) as defined by RECIST, Version 1.1 including bone-only disease

   - ECOG performance status 0 to 1

   - Adequate organ function

Exclusion Criteria:

   - For Part 3, prior treatment with CDK4/6 inhibitor, investigational oral SERDs or
   SERCAs in any setting

   - Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or
   leptomeningeal disease

   - Anticancer therapy within 14 days of first G1T48 dose or within 28 days for
   antibody-based therapy

   - Concurrent radiotherapy, radiotherapy within 14 days of first G1T48 dose, previous
   radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow

   - Prior hematopoietic stem cell or bone marrow transplantation

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Wyatt Forrest Gross
650-721-4076
Not Recruiting