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An Open-Label, Phase Ib Dose Escalation Trial of Oral Combination Therapy With MSC1936369B and SAR245409 in Subjects With Locally Advanced or Metastatic Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Locally Advanced Solid Tumor, Metastatic Solid Tumor, Breast Cancer, Non Small Cell Lung Cancer, Melanoma, Colorectal Cancer

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Trial Information

An Open-Label, Phase Ib Dose Escalation Trial of Oral Combination Therapy With MSC1936369B and SAR245409 in Subjects With Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria:

1. Subject with advanced solid tumors for which there is no approved therapy:

- Advanced solid tumor with diagnosed alteration in one or more of the following
GNA11 and/or

- A histologically or cytologically confirmed diagnosis of one of the following
solid tumors: pancreatic, thyroid, colorectal, non-small cell lung, endometrial,
renal, breast, ovarian carcinoma and melanoma

2. Subject with archived tumor tissue available for transfer to the Sponsor

3. Subject enrolled at lower dose level cohorts and MTD expansion cohorts must have
tumor available for biopsy and agree to pre-treatment and on-treatment tumor biopsies

4. Subject has measurable or evaluable disease by RECIST v1.1

5. Subject is aged ≥ 18 years

6. Subjects enrolled in disease specific expansion cohorts must fulfill all the
inclusion/exclusion criteria listed above with the following restriction to the
Inclusion Criterion number 1:

- Relapsed or refractory KRAS or NRAS mutated metastatic NSCLC with no approved
therapies, OR

- Relapsed or refractory metastatic triple negative breast cancer defined as
estrogen, progesterone and HER2 negative carcinoma of the breast with no
approved therapies, OR

- Relapsed or refractory metastatic CRC with dual KRAS and PIK3CA mutation with no
approved therapies, OR

- BRAF V600E/K mutated unresectable or metastatic melanoma after progression on
BRAF inhibitors

Additional inclusion criteria also apply

Exclusion Criteria:

1. Subject has been previously treated with a PI3K inhibitor or a MEK inhibitor and
taken off treatment due to treatment related adverse events.

2. Subject has received:

- Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other
anti-cancer therapy within 28 days of trial drug treatment

- Any investigational agent within 28 days of trial drug treatment c. Extensive
prior radiotherapy on more than 30% bone marrow reserves, or prior bone
marrow/stem cell transplantation

3. Subject has not recovered from toxicity due to prior therapy.

4. Subject has poor organ and marrow function as defined in the protocol.

5. Subject has a history of central nervous system metastases, unless subject has been
previously treated for CNS metastases.

6. Subject has a history of difficulty swallowing, malabsorption or other chronic
gastrointestinal disease .

7. Subject has a history of recent major surgery or trauma within the last 28 days.

8. Subject has participated in another clinical trial within the past 30 days.

Additional exclusion criteria also apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number and proportion of subjects with dose limiting toxicities

Outcome Description:

This will be used as the primary measure for determining the Maximum Tolerated Dose (MTD) of MSC1936369B and SAR245409 combination therapy.

Outcome Time Frame:

22 months

Safety Issue:


Principal Investigator

Rebecca S Heist, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:

EMR 200066-006



Start Date:

May 2011

Completion Date:

Related Keywords:

  • Locally Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Breast Cancer
  • Non Small Cell Lung Cancer
  • Melanoma
  • Colorectal Cancer
  • MEK inhibitor (Pimasertib)
  • PI3K/mTOR Inhibitor
  • Solid Tumor
  • Phase I
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Melanoma
  • Neoplasms



Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Cancer Therapy and Research CenterSan Antonio, Texas  78229
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Sarah Cannon Research InstituteNashville, Tennessee  37203
Pinnacle Oncology HematologyScottsdale, Arizona  85258